Trial Outcomes & Findings for 68Ga-OPS202 Study for Diagnostic Imaging of GEP NET (NCT NCT02162446)

Last Updated: 2019-10-02

Results Overview

An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

From start of IP administration to end of the study visit (approximately 28 to 36 days)

Results posted on

2019-10-02

Participant Flow

This open-label, micro-dosing study with 2 sequentially ascending single peptide doses was conducted in a single study center in Switzerland between 23 June 2014 and 14 January 2015.

A total of 12 participants with histologically confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP NET) and a previously performed somatostatin receptor scan were treated in this study. Each participant underwent a screening visit within 28 days prior to receiving the study's investigational product (IP).

Participant milestones

Participant milestones
Measure	All Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] microgram (μg) on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 megabecquerel (MBq) (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to three dimensional (3D) positron emission tomography/computed tomography (PET/CT) scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Age, Continuous	54.8 years STANDARD_DEVIATION 14.66 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Population: The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) Any AE	6 Participants	—	—
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) SAEs	0 Participants	—	—
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) ADRs	5 Participants	—	—

PRIMARY outcome

Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Population: The SAF included all participants of the FAS who received the investigational product, regardless of any protocol deviations.

Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication Laboratory parameters abnormalities	8 Participants	—	—
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication Vital sign abnormalities	7 Participants	—	—
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication 12-Lead ECG abnormalities	1 Participants	—	—
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication Physical examination abnormalities	9 Participants	—	—
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication Concomitant medications required	12 Participants	—	—

SECONDARY outcome

Timeframe: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

Population: The Intention-to-Treat (ITT) set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.

At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.

Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Total: At 0.5 hour	100 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Total: At 1 hour	100 percentage of participants	100 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Total: At 2 hour	100 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Total: At 4 hour	100 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Bone: At 0.5 hour	16.7 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Bone: At 1 hour	16.7 percentage of participants	16.7 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Bone: At 2 hour	16.7 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Bone: At 4 hour	16.7 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Liver: At 0.5 hour	75.0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Liver: At 1 hour	75.0 percentage of participants	75.0 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Liver: At 2 hour	75.0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Liver: At 4 hour	75.0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lung: At 0.5 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lung: At 1 hour	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lung: At 2 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lung: At 4 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lymph node: At 0.5 hour	58.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lymph node: At 1 hour	58.3 percentage of participants	58.3 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lymph node: At 2 hour	58.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Lymph node: At 4 hour	58.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Mamma: At 0.5 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Mamma: At 1 hour	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Mamma: At 2 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Mamma: At 4 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Pancreas: At 0.5 hour	8.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Pancreas: At 1 hour	8.3 percentage of participants	8.3 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Pancreas: At 2 hour	8.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Pancreas: At 4 hour	8.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Peritoneum: At 0.5 hour	8.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Peritoneum: At 1 hour	8.3 percentage of participants	8.3 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Peritoneum: At 2 hour	8.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Peritoneum: At 4 hour	8.3 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Small bowel: At 0.5 hour	25.0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Small bowel: At 1 hour	25.0 percentage of participants	25.0 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Small bowel: At 2 hour	25.0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Small bowel: At 4 hour	16.7 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Thyroid gland: At 0.5 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Thyroid gland: At 1 hour	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Thyroid gland: At 2 hour	0 percentage of participants	—	—
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding Thyroid gland: At 4 hour	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) n=12 Participants Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Spleen	16.343 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	15.997 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	14.308 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Stomach	6.713 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	7.630 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	5.305 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Malignant: Bone	4.394 SUVmax Standard Deviation 0.9396	4.153 SUVmax Standard Deviation 2.0270	4.455 SUVmax Standard Deviation 0.2425
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Malignant: Liver	12.135 SUVmax Standard Deviation 4.4660	10.468 SUVmax Standard Deviation 4.7970	8.458 SUVmax Standard Deviation 3.4840
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Malignant: Lymph node	15.192 SUVmax Standard Deviation 7.4318	16.289 SUVmax Standard Deviation 12.0091	14.602 SUVmax Standard Deviation 10.9725
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Malignant: Peritoneum	6.579 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	6.740 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	9.504 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Malignant: Small bowel	14.049 SUVmax Standard Deviation 0.2124	11.140 SUVmax Standard Deviation 7.9828	9.156 SUVmax Standard Deviation 1.0674
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Lung	—	3.410 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	3.131 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Lymph node	3.093 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Mamma	2.353 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	2.907 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	2.538 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Mediastinum	2.242 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Pancreas	14.086 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	8.693 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	6.659 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Small bowel	8.264 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	4.990 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 Benign: Thyroid gland	3.768 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Bone: At 2 hour	4.601 SUVmax Standard Deviation 1.3164	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Benign: Pancreas: At 0.5 hour	8.561 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Benign: Pancreas: At 1 hour	8.512 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	6.659 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Bone: At 0.5 hour	4.938 SUVmax Standard Deviation 1.1179	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Bone: At 1 hour	4.153 SUVmax Standard Deviation 2.0270	4.455 SUVmax Standard Deviation 0.2425	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Bone: At 4 hour	4.564 SUVmax Standard Deviation 1.0832	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Liver: At 0.5 hour	10.086 SUVmax Standard Deviation 5.0229	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Liver: At 1 hour	11.485 SUVmax Standard Deviation 6.3691	9.037 SUVmax Standard Deviation 3.9033	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Liver: At 2 hour	9.897 SUVmax Standard Deviation 4.3537	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Liver: At 4 hour	12.482 SUVmax Standard Deviation 5.9410	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Lymph node: At 0.5 hour	14.581 SUVmax Standard Deviation 9.7609	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Lymph node: At 1 hour	17.044 SUVmax Standard Deviation 11.6224	15.836 SUVmax Standard Deviation 10.9868	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Lymph node: At 2 hour	18.166 SUVmax Standard Deviation 10.6940	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Lymph node: At 4 hour	17.985 SUVmax Standard Deviation 13.5368	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Peritoneum: At 0.5 hour	3.293 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Peritoneum: At 1 hour	6.740 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	9.504 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Peritoneum: At 2 hour	7.484 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Peritoneum: At 4 hour	7.216 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Small bowel: At 0.5 hour	9.474 SUVmax Standard Deviation 5.8641	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Small bowel: At 1 hour	11.207 SUVmax Standard Deviation 4.5367	7.440 SUVmax Standard Deviation 2.8588	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Small bowel: At 2 hour	9.075 SUVmax Standard Deviation 4.9059	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Malignant: Small bowel: At 4 hour	14.695 SUVmax Standard Deviation 6.9926	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Benign: Pancreas: At 2 hour	8.734 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of Malignant and Benign Lesions for Session 2 Benign: Pancreas: At 4 hour	5.759 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—

SECONDARY outcome

Timeframe: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) n=12 Participants Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 Muscle	1.020 SUVmax Standard Deviation 0.3141	0.883 SUVmax Standard Deviation 0.2530	0.896 SUVmax Standard Deviation 0.1812
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 Liver	6.801 SUVmax Standard Deviation 1.9676	3.642 SUVmax Standard Deviation 1.6381	2.959 SUVmax Standard Deviation 0.8089
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 Peritoneum	0.776 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.927 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.401 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 Bone	0.610 SUVmax Standard Deviation 0.1801	0.739 SUVmax Standard Deviation 0.1780	0.636 SUVmax Standard Deviation 0.1207
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 Lymph node	2.229 SUVmax Standard Deviation 1.2017	1.870 SUVmax Standard Deviation 0.6967	2.368 SUVmax Standard Deviation 1.7112
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 Small bowel	4.180 SUVmax Standard Deviation 0.7893	2.080 SUVmax Standard Deviation 0.5162	1.707 SUVmax Standard Deviation 0.0636

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Mean SUVmax of RT for Session 2 Muscle: At 0.5 hour	0.923 SUVmax Standard Deviation 0.2260	—	—
Mean SUVmax of RT for Session 2 Liver: At 1 hour	4.040 SUVmax Standard Deviation 1.5213	3.480 SUVmax Standard Deviation 1.1863	—
Mean SUVmax of RT for Session 2 Liver: At 2 hour	4.103 SUVmax Standard Deviation 1.2389	—	—
Mean SUVmax of RT for Session 2 Lymph node: At 4 hour	1.989 SUVmax Standard Deviation 0.6904	—	—
Mean SUVmax of RT for Session 2 Muscle: At 1 hour	0.932 SUVmax Standard Deviation 0.2386	0.976 SUVmax Standard Deviation 0.2012	—
Mean SUVmax of RT for Session 2 Muscle: At 2 hour	1.127 SUVmax Standard Deviation 0.3343	—	—
Mean SUVmax of RT for Session 2 Muscle: At 4 hour	2.013 SUVmax Standard Deviation 0.6884	—	—
Mean SUVmax of RT for Session 2 Bone: At 0.5 hour	0.573 SUVmax Standard Deviation 0.3418	—	—
Mean SUVmax of RT for Session 2 Bone: At 1 hour	0.605 SUVmax Standard Deviation 0.3681	0.765 SUVmax Standard Deviation 0.1409	—
Mean SUVmax of RT for Session 2 Bone: At 2 hour	0.731 SUVmax Standard Deviation 0.0550	—	—
Mean SUVmax of RT for Session 2 Bone: At 4 hour	2.138 SUVmax Standard Deviation 0.7022	—	—
Mean SUVmax of RT for Session 2 Liver: At 0.5 hour	4.201 SUVmax Standard Deviation 1.3697	—	—
Mean SUVmax of RT for Session 2 Liver: At 4 hour	6.101 SUVmax Standard Deviation 2.7773	—	—
Mean SUVmax of RT for Session 2 Lymph node: At 0.5 hour	1.723 SUVmax Standard Deviation 0.9118	—	—
Mean SUVmax of RT for Session 2 Lymph node: At 1 hour	2.049 SUVmax Standard Deviation 0.7805	1.757 SUVmax Standard Deviation 1.1486	—
Mean SUVmax of RT for Session 2 Lymph node: At 2 hour	2.467 SUVmax Standard Deviation 1.3033	—	—
Mean SUVmax of RT for Session 2 Peritoneum: At 0.5 hour	1.864 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of RT for Session 2 Peritoneum: At 1 hour	1.038 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.163 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Mean SUVmax of RT for Session 2 Peritoneum: At 2 hour	0.856 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of RT for Session 2 Peritoneum: At 4 hour	1.501 SUVmax Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
Mean SUVmax of RT for Session 2 Small bowel: At 0.5 hour	2.519 SUVmax Standard Deviation 0.2743	—	—
Mean SUVmax of RT for Session 2 Small bowel: At 1 hour	2.571 SUVmax Standard Deviation 1.0644	1.608 SUVmax Standard Deviation 0.3677	—
Mean SUVmax of RT for Session 2 Small bowel: At 2 hour	2.124 SUVmax Standard Deviation 0.7382	—	—
Mean SUVmax of RT for Session 2 Small bowel: At 4 hour	3.177 SUVmax Standard Deviation 0.7174	—	—

SECONDARY outcome

Timeframe: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) n=12 Participants Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Liver (RT: Liver)	2.066 ratio Standard Deviation 0.9163	3.234 ratio Standard Deviation 1.8130	3.215 ratio Standard Deviation 1.8160
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Small bowel (RT: Small bowel)	3.427 ratio Standard Deviation 0.6978	6.017 ratio Standard Deviation 5.3303	5.355 ratio Standard Deviation 0.4256
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Bone (RT: Bone)	7.296 ratio Standard Deviation 0.6136	6.125 ratio Standard Deviation 4.2161	7.167 ratio Standard Deviation 1.7409
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Bone (RT: Muscle)	5.227 ratio Standard Deviation 1.7044	6.091 ratio Standard Deviation 2.1353	5.868 ratio Standard Deviation 0.4515
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Liver (RT: Muscle)	13.434 ratio Standard Deviation 7.3703	12.605 ratio Standard Deviation 7.9383	10.318 ratio Standard Deviation 5.7811
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Lymph node (RT: Lymph node)	9.548 ratio Standard Deviation 7.1592	9.320 ratio Standard Deviation 5.2590	11.034 ratio Standard Deviation 13.3938
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Lymph node (RT: Muscle)	15.110 ratio Standard Deviation 7.4282	19.861 ratio Standard Deviation 16.0492	18.349 ratio Standard Deviation 15.9027
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Peritoneum (RT: Peritoneum)	8.475 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	7.268 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	6.783 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Peritoneum (RT: Muscle)	8.366 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	9.170 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	11.399 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 Small bowel (RT: Muscle)	15.353 ratio Standard Deviation 7.1430	12.585 ratio Standard Deviation 6.1981	11.352 ratio Standard Deviation 2.5753

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Muscle): At 1 hour	5.528 ratio Standard Deviation 2.1555	5.530 ratio Standard Deviation 0.8944	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Muscle): At 2 hour	5.311 ratio Standard Deviation 2.1658	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Muscle): At 4 hour	2.331 ratio Standard Deviation 0.5535	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Liver): At 1 hour	3.071 ratio Standard Deviation 2.3858	2.514 ratio Standard Deviation 0.6087	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Lymph node): At 1 hour	10.109 ratio Standard Deviation 7.3722	14.166 ratio Standard Deviation 13.4067	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Peritoneum): At 2 hour	8.747 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Muscle): At 1 hour	8.508 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	10.060 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Muscle): At 0.5 hour	9.404 ratio Standard Deviation 5.2820	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Bone): At 0.5 hour	11.191 ratio Standard Deviation 8.6266	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Bone): At 1 hour	9.679 ratio Standard Deviation 9.2426	5.891 ratio Standard Deviation 0.7682	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Bone): At 2 hour	6.243 ratio Standard Deviation 1.3313	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Bone): At 4 hour	2.169 ratio Standard Deviation 0.2056	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Bone (RT: Muscle): At 0.5 hour	6.716 ratio Standard Deviation 1.4013	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Liver): At 0.5 hour	2.547 ratio Standard Deviation 1.5468	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Liver): At 2 hour	2.430 ratio Standard Deviation 0.9559	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Liver): At 4 hour	2.038 ratio Standard Deviation 0.6822	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Muscle): At 0.5 hour	11.534 ratio Standard Deviation 8.0671	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Muscle): At 1 hour	13.231 ratio Standard Deviation 10.4892	9.653 ratio Standard Deviation 5.1879	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Muscle): At 2 hour	9.383 ratio Standard Deviation 6.1356	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Liver (RT: Muscle): At 4 hour	6.974 ratio Standard Deviation 6.4729	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Lymph node): At 0.5 hour	13.448 ratio Standard Deviation 12.3973	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Lymph node): At 2 hour	9.722 ratio Standard Deviation 7.1821	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Lymph node): At 4 hour	9.889 ratio Standard Deviation 5.8842	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Muscle): At 0.5 hour	16.362 ratio Standard Deviation 9.1362	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Muscle): At 1 hour	20.434 ratio Standard Deviation 13.6060	18.562 ratio Standard Deviation 15.1302	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Muscle): At 2 hour	16.107 ratio Standard Deviation 9.5271	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Lymph node (RT: Muscle): At 4 hour	8.619 ratio Standard Deviation 3.7444	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Peritoneum): At 0.5 hour	1.767 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Peritoneum): At 1 hour	6.494 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	8.173 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Peritoneum): At 4 hour	4.809 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Muscle): At 0.5 hour	4.431 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Muscle): At 2 hour	7.709 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Peritoneum (RT: Muscle): At 4 hour	2.626 ratio Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Small bowel): At 0.5 hour	3.759 ratio Standard Deviation 2.1690	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Small bowel): At 1 hour	5.644 ratio Standard Deviation 4.9619	4.956 ratio Standard Deviation 2.8311	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Small bowel): At 2 hour	4.363 ratio Standard Deviation 2.5614	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Small bowel): At 4 hour	4.047 ratio Standard Deviation 1.6457	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Muscle): At 1 hour	11.787 ratio Standard Deviation 5.8090	7.678 ratio Standard Deviation 3.9023	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Muscle): At 2 hour	7.267 ratio Standard Deviation 3.8995	—	—
The 3D-SUV-R of Malignant Lesions for Session 2 Small bowel (RT: Muscle): At 4 hour	6.686 ratio Standard Deviation 1.5046	—	—

SECONDARY outcome

Timeframe: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Percent Change in 3D-SUV-R of Malignant Lesions Lymph node (RT: Muscle)	46.569 percent change Standard Deviation 61.4515	36.864 percent change Standard Deviation 79.3287	—
Percent Change in 3D-SUV-R of Malignant Lesions Small bowel (RT: Muscle)	2.447 percent change Standard Deviation 88.0324	-12.716 percent change Standard Deviation 57.3817	—
Percent Change in 3D-SUV-R of Malignant Lesions Bone (RT: Bone)	-13.315 percent change Standard Deviation 65.0759	-0.418 percent change Standard Deviation 32.2352	—
Percent Change in 3D-SUV-R of Malignant Lesions Bone (RT: Muscle)	16.042 percent change Standard Deviation 3.0132	20.052 percent change Standard Deviation 47.7825	—
Percent Change in 3D-SUV-R of Malignant Lesions Liver (RT: Liver)	51.938 percent change Standard Deviation 33.2221	50.766 percent change Standard Deviation 25.4179	—
Percent Change in 3D-SUV-R of Malignant Lesions Liver (RT: Muscle)	-5.165 percent change Standard Deviation 32.3975	-19.838 percent change Standard Deviation 37.5669	—
Percent Change in 3D-SUV-R of Malignant Lesions Lymph node (RT: Lymph node)	56.044 percent change Standard Deviation 94.8768	38.530 percent change Standard Deviation 117.3139	—
Percent Change in 3D-SUV-R of Malignant Lesions Peritoneum (RT: Peritoneum)	-14.239 percent change Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	-19.962 percent change Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Percent Change in 3D-SUV-R of Malignant Lesions Peritoneum (RT: Muscle)	9.619 percent change Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	36.256 percent change Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Percent Change in 3D-SUV-R of Malignant Lesions Small bowel (RT: Small bowel)	63.131 percent change Standard Deviation 122.3379	58.296 percent change Standard Deviation 19.8143	—

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0

For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Pancreas · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Pancreas · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Total · At 0.5 hour	5 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Total · At 1 hour	3 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Total · At 2 hour	4 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Total · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Bone · At 0.5 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Bone · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Bone · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Bone · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Liver · At 0.5 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Liver · At 1 hour	3 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Liver · At 2 hour	4 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Liver · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Lymph node · At 0.5 hour	7 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Lymph node · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Lymph node · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Lymph node · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Pancreas · At 0.5 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Pancreas · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Peritoneum · At 0.5 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Peritoneum · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Peritoneum · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Peritoneum · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Small bowel · At 0.5 hour	3 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Small bowel · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Small bowel · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location Small bowel · At 4 hour	0 Participants	—	—

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0

The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used.

Outcome measures

Outcome measures
Measure	All Participants n=11 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Muscle) · At 0.5 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Bone) · At 0.5 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Bone) · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Bone) · At 2 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Bone) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Muscle) · At 0.5 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Muscle) · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Muscle) · At 2 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Bone (RT: Muscle) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Liver) · At 0.5 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Liver) · At 1 hour	4 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Liver) · At 2 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Liver) · At 4 hour	3 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Muscle) · At 0.5 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Muscle) · At 1 hour	5 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Muscle) · At 2 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Liver (RT: Muscle) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Lymph node) · At 0.5 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Lymph node) · At 1 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Lymph node) · At 2 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Lymph node) · At 4 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Muscle) · At 0.5 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Muscle) · At 1 hour	5 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Muscle) · At 2 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Lymph node (RT: Muscle) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Peritoneum) · At 0.5 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Peritoneum) · At 1 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Peritoneum) · At 2 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Peritoneum) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Muscle) · At 0.5 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Muscle) · At 1 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Muscle) · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Peritoneum (RT: Muscle) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Small bowel) · At 0.5 hour	1 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Small bowel) · At 1 hour	2 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Small bowel) · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Small bowel) · At 4 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Muscle) · At 1 hour	3 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Muscle) · At 2 hour	0 Participants	—	—
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value Small bowel (RT: Muscle) · At 4 hour	0 Participants	—	—

SECONDARY outcome

Timeframe: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Best Diagnostic Scan Assessment At 0.5 hour	4.0 score on a scale Interval 2.0 to 5.0	—	—
Best Diagnostic Scan Assessment At 1 hour	5.0 score on a scale Interval 3.0 to 5.0	5.0 score on a scale Interval 3.0 to 5.0	—
Best Diagnostic Scan Assessment At 2 hour	4.5 score on a scale Interval 3.0 to 5.0	—	—
Best Diagnostic Scan Assessment At 4 hour	2.0 score on a scale Interval 1.0 to 4.0	—	—

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=12 participants at risk Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Infections and infestations Urinary tract infection	16.7% 2/12 • Number of events 2 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Gastrointestinal disorders Abdominal pain upper	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
General disorders Fatigue	16.7% 2/12 • Number of events 2 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Blood and lymphatic system disorders Eosinophilia	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Investigations Liver function test abnormal	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 1 • From start of IP administration to end of the study visit (approximately 28 to 36 days). The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.

Additional Information

Medical Director

Ipsen

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	All Participants n=12 Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.	ITT Population (Day 0) n=12 Participants Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.	ITT Population (Day 21) n=12 Participants Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Number of Malignant and Benign Lesions Detected for Session 1 Malignant: Peritoneum	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Lymph node	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Mediastinum	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Pancreas	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Small bowel	4.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	4.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Malignant: Total	9.3 lesion Standard Deviation 10.49	17.0 lesion Standard Deviation 17.31	20.1 lesion Standard Deviation 20.58
Number of Malignant and Benign Lesions Detected for Session 1 Malignant: Bone	1.0 lesion Standard Deviation 0.00	1.0 lesion Standard Deviation 0.00	1.0 lesion Standard Deviation 0.00
Number of Malignant and Benign Lesions Detected for Session 1 Malignant: Liver	8.6 lesion Standard Deviation 10.62	17.4 lesion Standard Deviation 17.98	21.7 lesion Standard Deviation 20.86
Number of Malignant and Benign Lesions Detected for Session 1 Malignant: Lymph node	2.5 lesion Standard Deviation 2.56	2.9 lesion Standard Deviation 2.10	2.5 lesion Standard Deviation 2.27
Number of Malignant and Benign Lesions Detected for Session 1 Malignant: Small bowel	1.0 lesion Standard Deviation 0.00	2.0 lesion Standard Deviation 1.41	1.5 lesion Standard Deviation 0.71
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Total	3.0 lesion Standard Deviation 1.83	1.8 lesion Standard Deviation 2.87	3.0 lesion Standard Deviation 3.16
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Lung	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	2.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	3.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Mamma	2.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	2.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	2.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Spleen	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Stomach	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.
Number of Malignant and Benign Lesions Detected for Session 1 Benign: Thyroid gland	1.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	0.0 lesion Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.