Trial Outcomes & Findings for To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) (NCT NCT03220217)
NCT ID: NCT03220217
Last Updated: 2021-01-14
Results Overview
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Day 1 and Days 16 to 22
Results posted on
2021-01-14
Participant Flow
This dose-confirmation study was conducted at 4 centres between September 2017 and August 2019. Adult subjects with somatostatin receptor subtype 2 (sstr2)-positive gastroenteropancreatic neuroendocrine tumour (GEP-NET) were randomised to investigational imaging product with Gallium-68 (68Ga)-satoreotide trizoxetan (68Ga-IPN01070, formerly known as 68Ga-OPS202).
The Screening Visit (Visit 1) was performed within 2 weeks prior to the first 68Ga-satoreotide trizoxetan administration. Subjects' eligibility was re-checked by the investigator at Visit 2 (Day 1) before randomisation to 1 of 3 study arms (A, B or C) with differing 68Ga-satoreotide trizoxetan peptide mass dose and radioactivity dose range combinations.
Participant milestones
| Measure |
Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.
Both injections were followed by positron emission tomography(PET)/computed tomography (CT) scan imaging 1 hour post dosing (up to 80 min).
|
Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.
Both injections were followed by positron emission tomography(PET)/computed tomography (CT) scan imaging 1 hour post dosing (up to 80 min).
|
Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Subject Missed Procedure
|
0
|
0
|
1
|
Baseline Characteristics
To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Baseline characteristics by cohort
| Measure |
Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 40-80 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
n=10 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
n=11 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the Per Protocol (PP) population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET/CT: All Organs
|
3.6 Ratio
Interval 0.73 to 15.0
|
3.8 Ratio
Interval 1.71 to 13.5
|
2.1 Ratio
Interval 0.64 to 4.41
|
2.6 Ratio
Interval 0.82 to 5.25
|
2.7 Ratio
Interval 0.91 to 16.25
|
2.5 Ratio
Interval 0.82 to 9.75
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET/CT: Primary Site
|
0.8 Ratio
Interval 0.5 to 1.0
|
0.8 Ratio
Interval 0.5 to 1.0
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET: Liver
|
2.6 Ratio
Interval 0.73 to 5.0
|
3.3 Ratio
Interval 1.0 to 7.0
|
2.9 Ratio
Interval 0.67 to 7.0
|
3.4 Ratio
Interval 1.33 to 9.0
|
2.4 Ratio
Interval 0.86 to 7.0
|
2.3 Ratio
Interval 0.62 to 6.0
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET: Lymph Nodes
|
2.0 Ratio
Interval 1.8 to 3.0
|
2.0 Ratio
Interval 1.6 to 4.0
|
2.2 Ratio
Interval 0.5 to 10.0
|
2.0 Ratio
Interval 0.5 to 14.0
|
3.8 Ratio
Interval 1.0 to 6.0
|
3.1 Ratio
Interval 0.75 to 4.0
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET/CT: Liver
|
2.1 Ratio
Interval 0.73 to 9.0
|
3.0 Ratio
Interval 2.0 to 8.0
|
2.9 Ratio
Interval 0.83 to 8.0
|
3.5 Ratio
Interval 1.5 to 11.0
|
2.4 Ratio
Interval 0.86 to 7.5
|
2.6 Ratio
Interval 0.76 to 5.17
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET/CT: Lymph Nodes
|
2.0 Ratio
Interval 1.8 to 3.0
|
2.0 Ratio
Interval 0.4 to 3.0
|
1.00 Ratio
Interval 0.0 to 8.0
|
0.9 Ratio
Interval 0.0 to 12.0
|
2.2 Ratio
Interval 1.25 to 5.0
|
1.6 Ratio
Interval 1.0 to 2.0
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET/CT: Bone
|
—
|
—
|
4.6 Ratio
Interval 4.6 to 4.6
|
3.6 Ratio
Interval 3.6 to 3.6
|
—
|
—
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET/CT: Lung
|
—
|
—
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 0.0 to 2.0
|
—
|
—
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET: All Organs
|
2.6 Ratio
Interval 0.73 to 19.0
|
3.9 Ratio
Interval 1.0 to 14.5
|
2.2 Ratio
Interval 1.0 to 4.5
|
2.6 Ratio
Interval 1.5 to 4.75
|
2.8 Ratio
Interval 0.91 to 13.5
|
2.7 Ratio
Interval 0.68 to 7.5
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET: Primary Site
|
0.8 Ratio
Interval 0.5 to 1.0
|
0.8 Ratio
Interval 0.5 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET: Bone
|
—
|
—
|
3.6 Ratio
Interval 3.6 to 3.6
|
3.8 Ratio
Interval 3.8 to 3.8
|
—
|
—
|
|
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
PET: Lung
|
—
|
—
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.5 Ratio
Interval 0.0 to 3.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: All Organs
|
2.7 Ratio
Interval 0.64 to 16.25
|
2.7 Ratio
Interval 0.82 to 13.5
|
3.1 Ratio
Interval 0.73 to 15.0
|
2.6 Ratio
Interval 0.64 to 13.5
|
2.6 Ratio
Interval 0.82 to 16.25
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Primary Site
|
1.0 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 0.5 to 1.0
|
1.0 Ratio
Interval 0.5 to 1.0
|
0.8 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Liver
|
2.3 Ratio
Interval 0.73 to 9.0
|
3.0 Ratio
Interval 0.76 to 11.0
|
2.2 Ratio
Interval 0.73 to 9.0
|
3.0 Ratio
Interval 0.83 to 8.0
|
2.7 Ratio
Interval 0.86 to 11.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Bone
|
4.6 Ratio
Interval 4.6 to 4.6
|
3.6 Ratio
Interval 3.6 to 3.6
|
—
|
4.6 Ratio
Interval 4.6 to 4.6
|
3.6 Ratio
Interval 3.6 to 3.6
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET: All Organs
|
2.6 Ratio
Interval 0.73 to 19.0
|
2.8 Ratio
Interval 0.68 to 14.5
|
2.6 Ratio
Interval 0.68 to 19.0
|
2.8 Ratio
Interval 1.0 to 14.5
|
2.7 Ratio
Interval 0.91 to 13.5
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Primary Site
|
1.0 Ratio
Interval 0.5 to 1.0
|
1.0 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 0.5 to 1.0
|
1.0 Ratio
Interval 0.5 to 1.0
|
1.0 Ratio
Interval 0.0 to 1.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Liver
|
2.6 Ratio
Interval 0.67 to 7.0
|
2.8 Ratio
Interval 0.62 to 9.0
|
2.6 Ratio
Interval 0.62 to 6.0
|
3.3 Ratio
Interval 0.67 to 7.0
|
2.8 Ratio
Interval 0.86 to 9.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Lymph Nodes
|
2.3 Ratio
Interval 0.5 to 10.0
|
2.0 Ratio
Interval 0.5 to 14.0
|
2.7 Ratio
Interval 0.75 to 4.0
|
2.0 Ratio
Interval 0.5 to 10.0
|
2.2 Ratio
Interval 0.5 to 14.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Bone
|
3.6 Ratio
Interval 3.6 to 3.6
|
3.8 Ratio
Interval 3.8 to 3.8
|
—
|
3.6 Ratio
Interval 3.6 to 3.6
|
3.8 Ratio
Interval 3.8 to 3.8
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Lymph Nodes
|
2.0 Ratio
Interval 0.0 to 8.0
|
1.3 Ratio
Interval 0.0 to 12.0
|
2.0 Ratio
Interval 1.0 to 3.0
|
1.3 Ratio
Interval 0.0 to 8.0
|
1.3 Ratio
Interval 0.0 to 12.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Lung
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 0.0 to 2.0
|
—
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.0 Ratio
Interval 0.0 to 2.0
|
—
|
|
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Lung
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.5 Ratio
Interval 0.0 to 3.0
|
—
|
0.5 Ratio
Interval 0.0 to 1.0
|
1.5 Ratio
Interval 0.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Lymph Nodes
|
7.4 Ratio
Interval 3.87 to 16.98
|
6.2 Ratio
Interval 3.22 to 13.76
|
5.1 Ratio
Interval 2.55 to 16.1
|
8.2 Ratio
Interval 1.54 to 13.7
|
5.7 Ratio
Interval 3.4 to 12.84
|
4.5 Ratio
Interval 3.5 to 18.69
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Primary Site
|
26.4 Ratio
Interval 7.04 to 45.84
|
17.5 Ratio
Interval 7.07 to 27.87
|
4.8 Ratio
Interval 4.57 to 33.81
|
18.1 Ratio
Interval 3.29 to 32.81
|
2.3 Ratio
Interval 2.3 to 2.3
|
2.2 Ratio
Interval 2.2 to 2.2
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Liver
|
5.5 Ratio
Interval 3.75 to 12.88
|
4.7 Ratio
Interval 3.56 to 9.96
|
4.2 Ratio
Interval 3.1 to 24.95
|
4.2 Ratio
Interval 3.05 to 29.33
|
3.6 Ratio
Interval 2.13 to 10.75
|
4.0 Ratio
Interval 3.07 to 22.48
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Bone
|
—
|
—
|
12.7 Ratio
Interval 12.7 to 12.7
|
9.2 Ratio
Interval 9.2 to 9.2
|
—
|
—
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Lung
|
—
|
—
|
—
|
—
|
1.1 Ratio
Interval 1.1 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Primary Site
|
5.9 Ratio
Interval 2.28 to 45.84
|
7.1 Ratio
Interval 2.22 to 32.81
|
7.0 Ratio
Interval 2.22 to 45.84
|
7.1 Ratio
Interval 4.57 to 33.81
|
3.3 Ratio
Interval 2.28 to 32.81
|
—
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Lymph Nodes
|
5.5 Ratio
Interval 2.55 to 16.98
|
5.2 Ratio
Interval 1.54 to 18.69
|
4.9 Ratio
Interval 3.5 to 18.69
|
5.3 Ratio
Interval 2.55 to 16.1
|
5.7 Ratio
Interval 1.54 to 13.7
|
—
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Bone
|
12.7 Ratio
Interval 12.7 to 12.7
|
9.2 Ratio
Interval 9.2 to 9.2
|
—
|
12.7 Ratio
Interval 12.7 to 12.7
|
9.2 Ratio
Interval 9.2 to 9.2
|
—
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Liver
|
4.1 Ratio
Interval 2.13 to 24.95
|
4.3 Ratio
Interval 3.05 to 29.33
|
4.3 Ratio
Interval 3.07 to 22.48
|
4.4 Ratio
Interval 3.1 to 24.95
|
4.1 Ratio
Interval 2.13 to 29.33
|
—
|
|
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Lung
|
1.1 Ratio
Interval 1.1 to 1.1
|
—
|
—
|
—
|
1.1 Ratio
Interval 1.1 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis. Note: image scores are presented as the cumulative sum of both readers' results across all subjects analysed per specified combination/visit; they do not represent summarised values.
A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis). For each PET/CT and PET assessment, each reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3. They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment. The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0". In case of equal quality, both assessments had a score of "1". The image quality score for PET/CT and PET readings as cumulative sum of readers' scores across all subjects by peptide mass and radioactivity dose range combination is presented. Score ranges from 0-16 with higher score indicating more assessments classed as superior.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Image Quality as Assessed by Independent Blinded Readers Quality Score
PET: Peptide mass 5-20 μg (Visit 2)
|
7 Cumulative Sum of Readers' Scores
|
14 Cumulative Sum of Readers' Scores
|
13 Cumulative Sum of Readers' Scores
|
—
|
—
|
—
|
|
Image Quality as Assessed by Independent Blinded Readers Quality Score
PET: Peptide mass 30-45 μg (Visit 3)
|
11 Cumulative Sum of Readers' Scores
|
15 Cumulative Sum of Readers' Scores
|
13 Cumulative Sum of Readers' Scores
|
—
|
—
|
—
|
|
Image Quality as Assessed by Independent Blinded Readers Quality Score
PET/CT: Peptide mass 30-45 μg (Visit 3)
|
13 Cumulative Sum of Readers' Scores
|
14 Cumulative Sum of Readers' Scores
|
13 Cumulative Sum of Readers' Scores
|
—
|
—
|
—
|
|
Image Quality as Assessed by Independent Blinded Readers Quality Score
PET/CT: Peptide mass 5-20 μg (Visit 2)
|
9 Cumulative Sum of Readers' Scores
|
10 Cumulative Sum of Readers' Scores
|
10 Cumulative Sum of Readers' Scores
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment. In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Primary Site
|
90.3 SUV
Interval 44.63 to 136.04
|
90.3 SUV
Interval 43.34 to 137.34
|
24.5 SUV
Interval 16.66 to 86.71
|
48.9 SUV
Interval 11.93 to 85.78
|
14.2 SUV
Interval 14.2 to 14.2
|
13.7 SUV
Interval 13.7 to 13.7
|
|
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Liver
|
24.2 SUV
Interval 18.25 to 49.16
|
22.9 SUV
Interval 18.01 to 59.83
|
9.5 SUV
Interval 6.74 to 63.68
|
16.0 SUV
Interval 9.56 to 78.43
|
12.4 SUV
Interval 6.95 to 30.07
|
17.7 SUV
Interval 10.62 to 30.28
|
|
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Lymph Nodes
|
24.7 SUV
Interval 19.52 to 40.74
|
35.7 SUV
Interval 16.69 to 41.11
|
28.5 SUV
Interval 9.03 to 83.06
|
27.7 SUV
Interval 5.25 to 53.79
|
13.8 SUV
Interval 6.08 to 21.73
|
12.7 SUV
Interval 6.15 to 21.33
|
|
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Bone
|
—
|
—
|
57.5 SUV
Interval 57.5 to 57.5
|
36.5 SUV
Interval 36.5 to 36.5
|
—
|
—
|
|
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Lung
|
—
|
—
|
—
|
—
|
1.8 SUV
Interval 1.8 to 1.8
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment. In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Primary Site
|
34.5 SUV
Interval 14.19 to 136.04
|
43.3 SUV
Interval 11.93 to 137.34
|
44.6 SUV
Interval 13.67 to 136.04
|
43.3 SUV
Interval 16.66 to 137.34
|
14.2 SUV
Interval 11.93 to 85.78
|
—
|
|
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Liver
|
15.6 SUV
Interval 6.74 to 63.68
|
21.1 SUV
Interval 9.56 to 78.43
|
20.0 SUV
Interval 10.62 to 49.16
|
20.1 SUV
Interval 6.74 to 63.68
|
13.3 SUV
Interval 6.95 to 78.43
|
—
|
|
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Bone
|
57.5 SUV
Interval 57.5 to 57.5
|
36.5 SUV
Interval 36.5 to 36.5
|
—
|
57.5 SUV
Interval 57.5 to 57.5
|
36.5 SUV
Interval 36.5 to 36.5
|
—
|
|
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Lymph Nodes
|
20.6 SUV
Interval 6.08 to 83.06
|
20.3 SUV
Interval 5.25 to 53.79
|
20.4 SUV
Interval 6.15 to 40.74
|
32.6 SUV
Interval 9.03 to 83.06
|
18.6 SUV
Interval 5.25 to 53.79
|
—
|
|
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Lung
|
1.8 SUV
Interval 1.8 to 1.8
|
—
|
—
|
—
|
1.8 SUV
Interval 1.8 to 1.8
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Lymph Nodes
|
4.0 Lesions
Interval 0.0 to 9.0
|
2.0 Lesions
Interval 0.0 to 6.0
|
4.0 Lesions
Interval 0.0 to 8.0
|
2.0 Lesions
Interval 0.0 to 12.0
|
6.0 Lesions
Interval 1.0 to 11.0
|
3.5 Lesions
Interval 1.0 to 10.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Primary Site
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Liver
|
8.5 Lesions
Interval 3.0 to 15.0
|
12.5 Lesions
Interval 3.0 to 22.0
|
8.0 Lesions
Interval 0.0 to 19.0
|
11.0 Lesions
Interval 0.0 to 21.0
|
14.5 Lesions
Interval 3.0 to 71.0
|
14.5 Lesions
Interval 3.0 to 93.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Bone
|
2.0 Lesions
Interval 1.0 to 6.0
|
1.0 Lesions
Interval 1.0 to 5.0
|
1.0 Lesions
Interval 0.0 to 55.0
|
1.0 Lesions
Interval 1.0 to 43.0
|
2.0 Lesions
Interval 1.0 to 10.0
|
3.0 Lesions
Interval 2.0 to 6.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Primary Site
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 1.0 to 1.0
|
1.0 Lesions
Interval 1.0 to 1.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Liver
|
7.5 Lesions
Interval 3.0 to 22.0
|
9.0 Lesions
Interval 3.0 to 23.0
|
8.0 Lesions
Interval 0.0 to 25.0
|
13.0 Lesions
Interval 0.0 to 26.0
|
14.0 Lesions
Interval 3.0 to 76.0
|
11.0 Lesions
Interval 3.0 to 78.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Lymph Nodes
|
4.0 Lesions
Interval 0.0 to 9.0
|
4.0 Lesions
Interval 0.0 to 10.0
|
3.0 Lesions
Interval 0.0 to 21.0
|
2.0 Lesions
Interval 0.0 to 18.0
|
6.5 Lesions
Interval 1.0 to 10.0
|
4.5 Lesions
Interval 1.0 to 8.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Bone
|
1.0 Lesions
Interval 1.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 43.0
|
1.0 Lesions
Interval 0.0 to 46.0
|
3.5 Lesions
Interval 2.0 to 15.0
|
3.0 Lesions
Interval 1.0 to 13.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Lung
|
0.5 Lesions
Interval 0.0 to 2.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
2.0 Lesions
Interval 0.0 to 4.0
|
2.0 Lesions
Interval 0.0 to 4.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Lung
|
0.0 Lesions
Interval 0.0 to 0.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by both peptide mass range and radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Primary Site
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Liver
|
9.0 Lesions
Interval 0.0 to 71.0
|
13.0 Lesions
Interval 0.0 to 93.0
|
11.5 Lesions
Interval 3.0 to 93.0
|
11.0 Lesions
Interval 0.0 to 22.0
|
11.0 Lesions
Interval 0.0 to 71.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Lymph Nodes
|
4.5 Lesions
Interval 0.0 to 11.0
|
2.0 Lesions
Interval 0.0 to 12.0
|
4.0 Lesions
Interval 0.0 to 10.0
|
2.0 Lesions
Interval 0.0 to 8.0
|
4.0 Lesions
Interval 0.0 to 12.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Bone
|
1.0 Lesions
Interval 0.0 to 55.0
|
1.5 Lesions
Interval 1.0 to 43.0
|
3.0 Lesions
Interval 1.0 to 6.0
|
1.0 Lesions
Interval 0.0 to 55.0
|
1.0 Lesions
Interval 1.0 to 43.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Liver
|
9.0 Lesions
Interval 0.0 to 76.0
|
11.0 Lesions
Interval 0.0 to 78.0
|
10.0 Lesions
Interval 3.0 to 78.0
|
8.0 Lesions
Interval 0.0 to 25.0
|
13.0 Lesions
Interval 0.0 to 76.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Lymph Nodes
|
6.0 Lesions
Interval 0.0 to 21.0
|
4.0 Lesions
Interval 0.0 to 18.0
|
4.0 Lesions
Interval 0.0 to 9.0
|
3.5 Lesions
Interval 0.0 to 21.0
|
6.0 Lesions
Interval 0.0 to 18.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Bone
|
1.5 Lesions
Interval 0.0 to 43.0
|
1.0 Lesions
Interval 0.0 to 46.0
|
1.0 Lesions
Interval 1.0 to 13.0
|
1.0 Lesions
Interval 0.0 to 43.0
|
2.0 Lesions
Interval 0.0 to 46.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Lung
|
0.5 Lesions
Interval 0.0 to 4.0
|
0.0 Lesions
Interval 0.0 to 4.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
2.0 Lesions
Interval 0.0 to 4.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Lung
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
—
|
|
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Primary Site
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
n=8 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Primary Site
|
0.5 Lesions
Interval -1.0 to 1.0
|
0.5 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 1.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Bone
|
2.0 Lesions
Interval 1.0 to 6.0
|
1.0 Lesions
Interval 1.0 to 5.0
|
1.0 Lesions
Interval 0.0 to 43.0
|
1.0 Lesions
Interval 1.0 to 31.0
|
2.0 Lesions
Interval 1.0 to 10.0
|
3.0 Lesions
Interval 2.0 to 6.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Lung
|
0.0 Lesions
Interval 0.0 to 0.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Primary Site
|
0.5 Lesions
Interval -1.0 to 1.0
|
0.5 Lesions
Interval -1.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Liver
|
4.0 Lesions
Interval -3.0 to 22.0
|
5.5 Lesions
Interval 0.0 to 21.0
|
8.0 Lesions
Interval -2.0 to 25.0
|
11.0 Lesions
Interval 0.0 to 26.0
|
5.0 Lesions
Interval -3.0 to 58.0
|
5.0 Lesions
Interval -8.0 to 60.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Lymph Nodes
|
2.0 Lesions
Interval 0.0 to 8.0
|
3.0 Lesions
Interval 0.0 to 10.0
|
1.0 Lesions
Interval -2.0 to 18.0
|
1.0 Lesions
Interval -2.0 to 13.0
|
5.5 Lesions
Interval 0.0 to 8.0
|
4.5 Lesions
Interval -1.0 to 7.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Bone
|
1.0 Lesions
Interval 1.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 1.0
|
1.0 Lesions
Interval 0.0 to 31.0
|
1.0 Lesions
Interval 0.0 to 34.0
|
3.5 Lesions
Interval 2.0 to 15.0
|
3.0 Lesions
Interval 1.0 to 13.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET: Lung
|
0.5 Lesions
Interval 0.0 to 2.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 2.0
|
2.0 Lesions
Interval -1.0 to 4.0
|
2.0 Lesions
Interval 0.0 to 4.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Lymph Nodes
|
2.0 Lesions
Interval 0.0 to 8.0
|
0.0 Lesions
Interval -3.0 to 4.0
|
0.0 Lesions
Interval -3.0 to 7.0
|
0.0 Lesions
Interval -2.0 to 11.0
|
3.0 Lesions
Interval 1.0 to 11.0
|
1.0 Lesions
Interval 0.0 to 10.0
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
PET/CT: Liver
|
6.0 Lesions
Interval -3.0 to 13.0
|
9.0 Lesions
Interval 3.0 to 14.0
|
8.0 Lesions
Interval -1.0 to 19.0
|
10.0 Lesions
Interval 0.0 to 21.0
|
4.0 Lesions
Interval -3.0 to 53.0
|
5.5 Lesions
Interval -5.0 to 75.0
|
SECONDARY outcome
Timeframe: Day 1 and Days 16 to 22Population: Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.
Outcome measures
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
|
Arm A: 30-45 μg/100-140 MBq
n=24 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
|
Arm B: 5-20 μg/100-140 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
|
Arm B: 30-45 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
|
Arm C: 5-20 μg/160-200 MBq
n=16 Participants
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
|
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
|
|---|---|---|---|---|---|---|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Primary Site
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.5 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 1.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Liver
|
7.0 Lesions
Interval -3.0 to 53.0
|
10.0 Lesions
Interval -5.0 to 75.0
|
5.5 Lesions
Interval -5.0 to 75.0
|
8.0 Lesions
Interval -1.0 to 19.0
|
10.0 Lesions
Interval -3.0 to 53.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Lymph Nodes
|
2.0 Lesions
Interval -3.0 to 11.0
|
1.0 Lesions
Interval -3.0 to 11.0
|
2.0 Lesions
Interval 0.0 to 10.0
|
0.0 Lesions
Interval -3.0 to 7.0
|
1.0 Lesions
Interval -2.0 to 11.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Bone
|
1.0 Lesions
Interval 0.0 to 43.0
|
1.5 Lesions
Interval 1.0 to 31.0
|
3.0 Lesions
Interval 1.0 to 6.0
|
1.0 Lesions
Interval 0.0 to 43.0
|
1.0 Lesions
Interval 1.0 to 31.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET/CT: Lung
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval 0.0 to 0.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
0.0 Lesions
Interval -1.0 to 1.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Primary Site
|
1.0 Lesions
Interval -1.0 to 1.0
|
1.0 Lesions
Interval -1.0 to 1.0
|
1.0 Lesions
Interval -1.0 to 1.0
|
0.5 Lesions
Interval -1.0 to 1.0
|
1.0 Lesions
Interval -1.0 to 1.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Liver
|
6.0 Lesions
Interval -3.0 to 58.0
|
6.0 Lesions
Interval -8.0 to 60.0
|
4.5 Lesions
Interval -8.0 to 60.0
|
6.0 Lesions
Interval -2.0 to 25.0
|
8.0 Lesions
Interval -3.0 to 58.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Lymph Nodes
|
4.5 Lesions
Interval -2.0 to 18.0
|
3.5 Lesions
Interval -2.0 to 13.0
|
4.0 Lesions
Interval -1.0 to 8.0
|
2.0 Lesions
Interval -2.0 to 18.0
|
5.0 Lesions
Interval -2.0 to 13.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Bone
|
1.5 Lesions
Interval 0.0 to 31.0
|
1.0 Lesions
Interval 0.0 to 34.0
|
1.0 Lesions
Interval 1.0 to 13.0
|
1.0 Lesions
Interval 0.0 to 31.0
|
2.0 Lesions
Interval 0.0 to 34.0
|
—
|
|
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
PET: Lung
|
0.0 Lesions
Interval -1.0 to 4.0
|
0.0 Lesions
Interval -1.0 to 4.0
|
0.0 Lesions
Interval 0.0 to 2.0
|
0.0 Lesions
Interval -1.0 to 2.0
|
2.0 Lesions
Interval -1.0 to 4.0
|
—
|
Adverse Events
Arm A: 5-20 μg/40-80 MBq
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm A: 30-45 μg/100-140 MBq
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B: 5-20 μg/100-140 MBq
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B: 30-45 μg/160-200 MBq
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm C: 5-20 μg/160-200 MBq
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C: 30-45 μg/40-80 MBq
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: 5-20 μg/40-80 MBq
n=8 participants at risk
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
|
Arm A: 30-45 μg/100-140 MBq
n=8 participants at risk
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
|
Arm B: 5-20 μg/100-140 MBq
n=9 participants at risk
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
|
Arm B: 30-45 μg/160-200 MBq
n=9 participants at risk
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
|
Arm C: 5-20 μg/160-200 MBq
n=10 participants at risk
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
|
Arm C: 30-45 μg/40-80 MBq
n=10 participants at risk
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
|
Overall
n=27 participants at risk
Total number of AEs experienced across all Arms.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
22.2%
2/9 • Number of events 2 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
14.8%
4/27 • Number of events 4 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
20.0%
2/10 • Number of events 2 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
7.4%
2/27 • Number of events 2 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 2 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
General disorders
Administration site pain
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
7.4%
2/27 • Number of events 3 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
General disorders
Feeling cold
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
7.4%
2/27 • Number of events 3 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
25.0%
2/8 • Number of events 2 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
22.2%
2/9 • Number of events 2 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
18.5%
5/27 • Number of events 6 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Investigations
Blood potassium increased
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Investigations
Blood urine present
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
10.0%
1/10 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/8 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
11.1%
1/9 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/9 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
0.00%
0/10 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
3.7%
1/27 • Number of events 1 • Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place