Trial Outcomes & Findings for Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (NCT NCT04410133)
NCT ID: NCT04410133
Last Updated: 2025-08-28
Results Overview
Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Results posted on
2025-08-28
Participant Flow
Participant milestones
| Measure |
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan
Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.
|
|---|---|
|
Overall Study
STARTED
|
151
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Baseline characteristics by cohort
| Measure |
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan
n=151 Participants
Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
70 Participants
n=5 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 11.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Height (cm)
|
168.25 cm
STANDARD_DEVIATION 10.002 • n=5 Participants
|
|
Weight (kg)
|
78.72 kg
STANDARD_DEVIATION 19.665 • n=5 Participants
|
|
Body mass index (kg/m2)
|
27.66 Kg/m2
STANDARD_DEVIATION 6.314 • n=5 Participants
|
|
ECOG
0
|
40 Participants
n=5 Participants
|
|
ECOG
1
|
96 Participants
n=5 Participants
|
|
ECOG
2
|
15 Participants
n=5 Participants
|
|
ECOG
3
|
0 Participants
n=5 Participants
|
|
ECOG
4
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=42 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=41 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=41 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=109 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=110 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=110 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level
|
23.8 percentage
Interval 12.1 to 39.5
|
34.1 percentage
Interval 20.1 to 50.6
|
36.6 percentage
Interval 22.1 to 53.1
|
82.6 percentage
Interval 74.1 to 89.2
|
70.9 percentage
Interval 61.5 to 79.2
|
70.9 percentage
Interval 61.5 to 79.2
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=29 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=46 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=47 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=122 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=105 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=104 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
|
34.5 percentage
Interval 17.9 to 54.3
|
30.4 percentage
Interval 17.7 to 45.8
|
31.9 percentage
Interval 19.1 to 47.1
|
73.8 percentage
Interval 65.0 to 81.3
|
74.3 percentage
Interval 64.8 to 82.5
|
75.0 percentage
Interval 65.6 to 83.0
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Population: Each participant may have more than one lesion (one reference lesion, and/or other equivocal lesions and/or additional PET lesions if applicable). At the participant level, if the reference lesion is indeterminate, then the worst case is used to impute the indeterminate finding into positive or negative. However, at the lesion level, lesions with indeterminate findings are excluded i.e. only lesions with positive or negative finding are included in the analysis.
To assess lesion-level PPA \& NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=49 Lesions
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=49 Lesions
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=49 Lesions
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=138 Lesions
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=138 Lesions
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=138 Lesions
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
|
18.4 percentage
Interval 7.3 to 29.4
|
28.6 percentage
Interval 15.8 to 41.4
|
30.6 percentage
Interval 17.7 to 43.5
|
84.1 percentage
Interval 77.4 to 90.7
|
74.6 percentage
Interval 66.6 to 82.7
|
73.2 percentage
Interval 65.0 to 81.4
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.To assess lesion-level PPV \& NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=31 Lesions
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=49 Lesions
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=52 Lesions
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=156 Lesions
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=105 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=135 Lesions
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
|
29.0 percentage
Interval 12.1 to 45.9
|
28.6 percentage
Interval 15.2 to 42.0
|
28.8 percentage
Interval 15.3 to 42.4
|
74.4 percentage
Interval 65.5 to 83.2
|
74.6 percentage
Interval 65.4 to 83.9
|
74.8 percentage
Interval 65.8 to 83.8
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Population: All subjects with a positive or negative Standard of Reference (SoR), with outcome measures categorized by tumor type.
Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to primary tumor type.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=42 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=41 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=41 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=109 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=110 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=110 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Melanoma
|
50.0 percentage
Interval 1.3 to 98.7
|
50.0 percentage
Interval 1.3 to 98.7
|
0.0 percentage
Interval 0.0 to 84.2
|
83.3 percentage
Interval 58.6 to 96.4
|
72.2 percentage
Interval 46.5 to 90.3
|
66.7 percentage
Interval 41.0 to 86.7
|
|
Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Breast
|
10.0 percentage
Interval 0.3 to 44.5
|
30.0 percentage
Interval 6.7 to 65.3
|
40.0 percentage
Interval 12.2 to 73.8
|
78.3 percentage
Interval 56.3 to 92.5
|
65.2 percentage
Interval 42.7 to 83.6
|
73.9 percentage
Interval 51.6 to 89.8
|
|
Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Lung Cancer
|
29.2 percentage
Interval 12.6 to 51.1
|
39.1 percentage
Interval 19.7 to 61.5
|
43.5 percentage
Interval 23.2 to 65.5
|
85.4 percentage
Interval 72.2 to 93.9
|
69.4 percentage
Interval 54.6 to 81.8
|
67.3 percentage
Interval 52.5 to 80.1
|
|
Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Non Lung/Breast/Melanoma
|
16.7 percentage
Interval 0.4 to 64.1
|
16.7 percentage
Interval 0.4 to 64.1
|
16.7 percentage
Interval 0.4 to 64.1
|
80.0 percentage
Interval 56.3 to 94.3
|
80.0 percentage
Interval 56.3 to 94.3
|
80.0 percentage
Interval 56.3 to 94.3
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Population: All subjects with a positive or negative finding by BIE, with outcome measures categorized by tumor type.
Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to primary tumor type.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=29 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=46 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=47 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=122 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=105 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=104 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Melanoma
|
25.0 percentage
Interval 0.6 to 80.6
|
16.7 percentage
Interval 0.4 to 64.1
|
0.0 percentage
Interval 0.0 to 45.9
|
93.8 percentage
Interval 69.8 to 99.8
|
92.9 percentage
Interval 66.1 to 99.8
|
85.7 percentage
Interval 57.2 to 98.2
|
|
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Breast
|
16.7 percentage
Interval 0.4 to 64.1
|
27.3 percentage
Interval 6.0 to 61.0
|
40.0 percentage
Interval 12.2 to 73.8
|
66.7 percentage
Interval 46.0 to 83.5
|
68.2 percentage
Interval 45.1 to 86.1
|
73.9 percentage
Interval 51.6 to 89.8
|
|
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Lung Cancer
|
50.0 percentage
Interval 23.0 to 77.0
|
37.5 percentage
Interval 18.8 to 59.4
|
38.5 percentage
Interval 20.2 to 59.4
|
70.7 percentage
Interval 57.3 to 81.9
|
70.8 percentage
Interval 55.9 to 83.1
|
71.7 percentage
Interval 56.5 to 84.0
|
|
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
Non Lung/Breast/Melanoma
|
20.0 percentage
Interval 0.5 to 71.6
|
20.0 percentage
Interval 0.5 to 71.6
|
20.0 percentage
Interval 0.5 to 71.6
|
76.2 percentage
Interval 52.8 to 91.8
|
76.2 percentage
Interval 52.8 to 91.8
|
76.2 percentage
Interval 52.8 to 91.8
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Population: All subjects with a positive or negative Standard of Reference (SoR), with outcome measures categorized by concurrent Immunotherapy.
Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=42 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=41 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=41 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=109 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=110 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=110 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy
Received Concurrent Immunotherapy
|
0.0 percentage
Interval 0.0 to 45.9
|
16.7 percentage
Interval 0.4 to 64.1
|
16.7 percentage
Interval 0.4 to 64.1
|
100.0 percentage
Interval 88.4 to 100.0
|
86.7 percentage
Interval 69.3 to 96.2
|
90.0 percentage
Interval 73.5 to 97.9
|
|
Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy
Did Not Receive Concurrent Immunotherapy
|
27.8 percentage
Interval 14.2 to 45.2
|
37.1 percentage
Interval 21.5 to 55.1
|
40.0 percentage
Interval 23.9 to 57.9
|
75.9 percentage
Interval 65.0 to 84.9
|
65.0 percentage
Interval 53.5 to 75.3
|
63.8 percentage
Interval 52.2 to 74.2
|
SECONDARY outcome
Timeframe: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.Population: All subjects with a positive or negative finding by BIE, with outcome measures categorized by concurrent Immunotherapy.
Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=29 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
n=46 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
n=47 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
n=122 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
n=105 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
n=104 Participants
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy
Received Concurrent Immunotherapy
|
—
|
20.0 percentage
Interval 0.5 to 71.6
|
25.0 percentage
Interval 0.6 to 80.6
|
83.3 percentage
Interval 67.2 to 93.6
|
83.9 percentage
Interval 66.3 to 94.6
|
84.4 percentage
Interval 67.2 to 94.7
|
|
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy
Did Not Receive Concurrent Immunotherapy
|
34.5 percentage
Interval 17.9 to 54.3
|
31.7 percentage
Interval 18.1 to 48.1
|
32.6 percentage
Interval 19.1 to 48.5
|
69.8 percentage
Interval 58.9 to 79.2
|
70.3 percentage
Interval 58.5 to 80.3
|
70.8 percentage
Interval 58.9 to 81.0
|
SECONDARY outcome
Timeframe: Follow up through 6 months after PET scan.Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Clinical Usefulness
|
112 Days
Interval 77.0 to 142.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow up through 6 months after PET scan.Population: Subjects with Additional Metastases Identified on Fluciclovine (18F) PET vs SoC MRI
Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Clinical Usefulness
|
1.3 percentage
Interval 0.2 to 4.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow up through 6 months after PET scan.Population: Subjects with Changes to Diagnostic Plan on Reference Lesion Following Fluciclovine (18F) PET
Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Clinical Usefulness
|
26.5 percentage
Interval 19.7 to 34.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PET Scan Day 1Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive \[1st reader\] / Positive \[2nd reader\], Negative/Negative) is presented.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Inter-reader Reproducibility
Reader 1 vs Reader 2
|
86.1 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Inter-reader Reproducibility
Reader 1 vs Reader 3
|
84.1 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Inter-reader Reproducibility
Reader 2 vs Reader 3
|
91.4 percentage
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PET Scan Day 1Pairwise comparisons of the initial read vs re-read of a subset of PET scans for each reader at the subject-level. The percentage of results in agreement (i.e. Positive \[initial read\] / Positive \[re-read\], Negative/Negative) is presented.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=31 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Intra-reader Reproducibility
Reader 1 initial read vs re-read
|
93.5 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Intra-reader Reproducibility
Reader 2 initial read vs re-read
|
93.5 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Intra-reader Reproducibility
Reader 3 initial read vs re-read
|
100.0 percentage
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The vital signs collected between 5 to 60 minutes before and after the PET scan.Population: Collected and Reported
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Systolic Blood Pressure: Pre-IMP Injection
|
128.7 mmHg
Standard Deviation 17.25
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Systolic Blood Pressure: Post PET Scan
|
132.4 mmHg
Standard Deviation 15.25
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Systolic Blood Pressure: Change from Pre to Post
|
3.5 mmHg
Standard Deviation 12.81
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Diastolic Blood Pressure: Pre-IMP Injection
|
75.4 mmHg
Standard Deviation 10.69
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Diastolic Blood Pressure: Post PET Scan
|
77.0 mmHg
Standard Deviation 10.86
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Diastolic Blood Pressure: Change from Pre to Post
|
1.5 mmHg
Standard Deviation 7.45
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The vital signs collected between 5 to 60 minutes before and after the PET scan.Population: Collected and Reported
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate
Heart Rate: Pre-IMP Injection
|
76.2 beat/min
Standard Deviation 13.53
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate
Heart Rate: Post PET Scan
|
74.5 beat/min
Standard Deviation 12.93
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate
Heart Rate: Change from Pre to Post
|
-1.7 beat/min
Standard Deviation 8.43
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The vital signs collected between 5 to 60 minutes before and after the PET scan.Population: Collected and Reported
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate
Respiratory Rate: Pre-IMP Injection
|
16.7 breaths/min
Standard Deviation 2.76
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate
Respiratory Rate: Post PET Scan
|
16.5 breaths/min
Standard Deviation 2.72
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate
Respiratory Rate: Change from Pre to Post
|
-0.2 breaths/min
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The vital signs collected between 5 to 60 minutes before and after the PET scan.Population: Collected and Reported
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Outcome measures
| Measure |
Reader 1 - Positive Percent Agreement (PPA)
n=151 Participants
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 2 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 3 - Positive Percent Agreement (PPA)
Only subjects with a positive standard of reference are included in the denominator for each reader.
|
Reader 1 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 2 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
Reader 3 - Negative Percent Agreement (NPA)
Only subjects with a negative standard of reference are included in the denominator for each reader.
|
|---|---|---|---|---|---|---|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature
Body Temperature: Pre-IMP Injection
|
36.53 degrees Celsius
Standard Deviation 0.419
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature
Body Temperature: Post PET Scan
|
36.53 degrees Celsius
Standard Deviation 0.455
|
—
|
—
|
—
|
—
|
—
|
|
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature
Body Temperature: Change from Pre to Post
|
-0.00 degrees Celsius
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan
n=151 participants at risk
Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.
|
|---|---|
|
Nervous system disorders
Seizure
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
Other adverse events
| Measure |
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan
n=151 participants at risk
Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.
|
|---|---|
|
General disorders
Fatigue
|
2.6%
4/151 • Number of events 4 • Treatment emerging AEs were captured within 48 hours.
|
|
General disorders
Infusion site bruising
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
General disorders
Injection site reaction
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Nervous system disorders
Dizziness
|
1.3%
2/151 • Number of events 2 • Treatment emerging AEs were captured within 48 hours.
|
|
Nervous system disorders
Headache
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Nervous system disorders
Paraesthesia
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Nervous system disorders
Seizure
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/151 • Number of events 2 • Treatment emerging AEs were captured within 48 hours.
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Infections and infestations
Hordeolum
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Psychiatric disorders
Insomnia
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
|
Vascular disorders
Hypertension
|
0.66%
1/151 • Number of events 1 • Treatment emerging AEs were captured within 48 hours.
|
Additional Information
Head of Research and Development
Blue Earth Diagnostics
Phone: +44 (0) 1865 784 186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place