To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

• Sponsor: Ipsen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03220217
• Collaborator: (none)
• Enrollment: 29
• Locations: 5
• Arms: 3
• Actual Duration (Months): 22.3
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-IPN01070 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can be seen in the PET scanner.

Condition or Disease	Intervention/Treatment	Phase
Gastro-Enteropancreatic Neuroendocrine Tumor	Drug: Satoreotide trizoxetan 5-20μg; Drug: Satoreotide trizoxetan 30-45μg	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
• Primary Purpose: Diagnostic
• Official Title: A Multicentre, Randomised, Dose-confirmation, Factorial Phase II Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
• Actual Study Start Date: Sep 26, 2017
• Actual Primary Completion Date: Jul 25, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5-20μg/40-80 MBq, 30-45μg/100-140 MBq Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.	Drug: Satoreotide trizoxetan 5-20μg; Positron emission tomography (PET) imaging agent; Other Names: 68Ga-OPS202 5-20μg, 68Ga-IPN01070 5-20μg ; Drug: Satoreotide trizoxetan 30-45μg; Positron emission tomography (PET) imaging agent; Other Names: 68Ga-OPS202 30-45μg, 68Ga-IPN01070 30-45μg
Experimental: 5-20μg/100-140 MBq, 30-45μg/160-200 MBq Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.	Drug: Satoreotide trizoxetan 5-20μg; Positron emission tomography (PET) imaging agent; Other Names: 68Ga-OPS202 5-20μg, 68Ga-IPN01070 5-20μg ; Drug: Satoreotide trizoxetan 30-45μg; Positron emission tomography (PET) imaging agent; Other Names: 68Ga-OPS202 30-45μg, 68Ga-IPN01070 30-45μg
Experimental: 5-20μg/160-200 MBq, 30-45μg/40-80 MBq Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.	Drug: Satoreotide trizoxetan 5-20μg; Positron emission tomography (PET) imaging agent; Other Names: 68Ga-OPS202 5-20μg, 68Ga-IPN01070 5-20μg ; Drug: Satoreotide trizoxetan 30-45μg; Positron emission tomography (PET) imaging agent; Other Names: 68Ga-OPS202 30-45μg, 68Ga-IPN01070 30-45μg

Outcome Measures

Primary Outcome Measures

1. Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.

2. Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.

Secondary Outcome Measures

1. Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range [Day 1 and Days 16 to 22]

   For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.

2. Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.

3. Image Quality as Assessed by Independent Blinded Readers Quality Score [Day 1 and Days 16 to 22]

   A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis). For each PET/CT and PET assessment, each reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3. They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment. The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0". In case of equal quality, both assessments had a score of "1". The image quality score for PET/CT and PET readings as cumulative sum of readers' scores across all subjects by peptide mass and radioactivity dose range combination is presented. Score ranges from 0-16 with higher score indicating more assessments classed as superior.

4. Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment. In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.

5. Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment. In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.

6. Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range [Day 1 and Days 16 to 22]

   For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.

7. Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by both peptide mass range and radioactivity dose range.

8. Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range [Day 1 and Days 16 to 22]

   For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.

9. Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges [Day 1 and Days 16 to 22]

   For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification

• Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility

• Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive

• Adequate bone marrow, liver and renal function

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

• Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs

• Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration

• Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide

• Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90095
2	Medical University of Innsbruck	Innsbruck		Austria	A-6020
3	University Clinic for Radiology and Nuclear Medicine	Vienna		Austria	A-1090
4	Aarhus University Hospital	Aarhus		Denmark	DK-8000
5	Rigshospitalet, University of Copenhagen	Copenhagen		Denmark	DK-2100

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

• Study Protocol - May 20, 2019
• Statistical Analysis Plan - Oct 28, 2019

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT03220217
• Other Study ID Numbers: D-FR-01070-002; 2016-004928-39
• First Posted: Jul 18, 2017
• Last Update Posted: Jan 14, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroendocrine Tumors

Study Results

Participant Flow

Recruitment Details	This dose-confirmation study was conducted at 4 centres between September 2017 and August 2019. Adult subjects with somatostatin receptor subtype 2 (sstr2)-positive gastroenteropancreatic neuroendocrine tumour (GEP-NET) were randomised to investigational imaging product with Gallium-68 (68Ga)-satoreotide trizoxetan (68Ga-IPN01070, formerly known as 68Ga-OPS202).
Pre-assignment Detail	The Screening Visit (Visit 1) was performed within 2 weeks prior to the first 68Ga-satoreotide trizoxetan administration. Subjects' eligibility was re-checked by the investigator at Visit 2 (Day 1) before randomisation to 1 of 3 study arms (A, B or C) with differing 68Ga-satoreotide trizoxetan peptide mass dose and radioactivity dose range combinations.

Arm/Group Title	Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq	Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq	Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
Arm/Group Description	Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq. Both injections were followed by positron emission tomography(PET)/computed tomography (CT) scan imaging 1 hour post dosing (up to 80 min).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
Period Title: Overall Study
STARTED	8	10	11
COMPLETED	8	9	10
NOT COMPLETED	0	1	1

Baseline Characteristics

Arm/Group Title	Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq	Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq	Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq	Total
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 40-80 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).	Total of all reporting groups
Overall Participants	8	10	11	29
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 37.5%	4 40%	8 72.7%	15 51.7%
>=65 years	5 62.5%	6 60%	3 27.3%	14 48.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.5 (11.1)	67.6 (6.4)	60.7 (12.3)	65.8 (10.8)
Sex: Female, Male (Count of Participants)
Female	2 25%	6 60%	2 18.2%	10 34.5%
Male	6 75%	4 40%	9 81.8%	19 65.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 9.1%	1 3.4%
White	8 100%	10 100%	10 90.9%	28 96.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Description	For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the Per Protocol (PP) population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Arm A: 5-20 μg/40-80 MBq	Arm A: 30-45 μg/100-140 MBq	Arm B: 5-20 μg/100-140 MBq	Arm B: 30-45 μg/160-200 MBq	Arm C: 5-20 μg/160-200 MBq	Arm C: 30-45 μg/40-80 MBq
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
Measure Participants	8	8	8	8	8	8
PET/CT: All Organs	3.6	3.8	2.1	2.6	2.7	2.5
PET/CT: Primary Site	0.8	0.8	0.5	1.0	1.0	1.0
PET/CT: Liver	2.1	3.0	2.9	3.5	2.4	2.6
PET/CT: Lymph Nodes	2.0	2.0	1.00	0.9	2.2	1.6
PET/CT: Bone	4.6	3.6
PET/CT: Lung	0.5	1.0
PET: All Organs	2.6	3.9	2.2	2.6	2.8	2.7
PET: Primary Site	0.8	0.8	1.0	0.5	1.0	1.0
PET: Liver	2.6	3.3	2.9	3.4	2.4	2.3
PET: Lymph Nodes	2.0	2.0	2.2	2.0	3.8	3.1
PET: Bone	3.6	3.8
PET: Lung	0.5	1.5

2. Primary Outcome

Title	Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
Description	For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Peptide Mass Dose Range 5-20 μg	Peptide Mass Dose Range 30-45 μg	Radioactivity Dose Range 40-80 MBq	Radioactivity Dose Range 100-140 MBq	Radioactivity Dose Range 160-200 MBq
Arm/Group Description	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).	Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Measure Participants	24	24	16	16	16
PET/CT: All Organs	2.7	2.7	3.1	2.6	2.6
PET/CT: Primary Site	1.0	1.0	1.0	0.8	1.0
PET/CT: Liver	2.3	3.0	2.2	3.0	2.7
PET/CT: Lymph Nodes	2.0	1.3	2.0	1.3	1.3
PET/CT: Bone	4.6	3.6	4.6	3.6
PET/CT: Lung	0.5	1.0	0.5	1.0
PET: All Organs	2.6	2.8	2.6	2.8	2.7
PET: Primary Site	1.0	1.0	1.0	1.0	1.0
PET: Liver	2.6	2.8	2.6	3.3	2.8
PET: Lymph Nodes	2.3	2.0	2.7	2.0	2.2
PET: Bone	3.6	3.8	3.6	3.8
PET: Lung	0.5	1.5	0.5	1.5

3. Secondary Outcome

Title	Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Description	For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Arm A: 5-20 μg/40-80 MBq	Arm A: 30-45 μg/100-140 MBq	Arm B: 5-20 μg/100-140 MBq	Arm B: 30-45 μg/160-200 MBq	Arm C: 5-20 μg/160-200 MBq	Arm C: 30-45 μg/40-80 MBq
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Measure Participants	8	8	8	8	8	8
Primary Site	26.4	17.5	4.8	18.1	2.3	2.2
Liver	5.5	4.7	4.2	4.2	3.6	4.0
Lymph Nodes	7.4	6.2	5.1	8.2	5.7	4.5
Bone	12.7	9.2
Lung	1.1

4. Secondary Outcome

Title	Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Description	For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Peptide Mass Dose Range 5-20 μg	Peptide Mass Dose Range 30-45 μg	Radioactivity Dose Range 40-80 MBq	Radioactivity Dose Range 100-140 MBq	Radioactivity Dose Range 160-200 MBq
Arm/Group Description	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).	Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Measure Participants	24	24	16	16	16
Primary Site	5.9	7.1	7.0	7.1	3.3
Liver	4.1	4.3	4.3	4.4	4.1
Lymph Nodes	5.5	5.2	4.9	5.3	5.7
Bone	12.7	9.2	12.7	9.2
Lung	1.1	1.1

5. Secondary Outcome

Title	Image Quality as Assessed by Independent Blinded Readers Quality Score
Description	A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis). For each PET/CT and PET assessment, each reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3. They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment. The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0". In case of equal quality, both assessments had a score of "1". The image quality score for PET/CT and PET readings as cumulative sum of readers' scores across all subjects by peptide mass and radioactivity dose range combination is presented. Score ranges from 0-16 with higher score indicating more assessments classed as superior.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis. Note: image scores are presented as the cumulative sum of both readers' results across all subjects analysed per specified combination/visit; they do not represent summarised values.

Arm/Group Title	Radioactivity Dose Range 40-80 MBq	Radioactivity Dose Range 100-140 MBq	Radioactivity Dose Range 160-200 MBq
Arm/Group Description	Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Measure Participants	16	16	16
PET/CT: Peptide mass 5-20 μg (Visit 2)	9	10	10
PET/CT: Peptide mass 30-45 μg (Visit 3)	13	14	13
PET: Peptide mass 5-20 μg (Visit 2)	7	14	13
PET: Peptide mass 30-45 μg (Visit 3)	11	15	13

6. Secondary Outcome

Title	Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Description	For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment. In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Arm A: 5-20 μg/40-80 MBq	Arm A: 30-45 μg/100-140 MBq	Arm B: 5-20 μg/100-140 MBq	Arm B: 30-45 μg/160-200 MBq	Arm C: 5-20 μg/160-200 MBq	Arm C: 30-45 μg/40-80 MBq
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Measure Participants	8	8	8	8	8	8
Primary Site	90.3	90.3	24.5	48.9	14.2	13.7
Liver	24.2	22.9	9.5	16.0	12.4	17.7
Lymph Nodes	24.7	35.7	28.5	27.7	13.8	12.7
Bone	57.5	36.5
Lung	1.8

7. Secondary Outcome

Title	Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Description	For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment. In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Peptide Mass Dose Range 5-20 μg	Peptide Mass Dose Range 30-45 μg	Radioactivity Dose Range 40-80 MBq	Radioactivity Dose Range 100-140 MBq	Radioactivity Dose Range 160-200 MBq
Arm/Group Description	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).	Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Measure Participants	24	24	16	16	16
Primary Site	34.5	43.3	44.6	43.3	14.2
Liver	15.6	21.1	20.0	20.1	13.3
Lymph Nodes	20.6	20.3	20.4	32.6	18.6
Bone	57.5	36.5	57.5	36.5
Lung	1.8	1.8

8. Secondary Outcome

Title	Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
Description	For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Arm A: 5-20 μg/40-80 MBq	Arm A: 30-45 μg/100-140 MBq	Arm B: 5-20 μg/100-140 MBq	Arm B: 30-45 μg/160-200 MBq	Arm C: 5-20 μg/160-200 MBq	Arm C: 30-45 μg/40-80 MBq
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Measure Participants	8	8	8	8	8	8
PET/CT: Primary Site	1.0	1.0	0.0	0.5	1.0	1.0
PET/CT: Liver	8.5	12.5	8.0	11.0	14.5	14.5
PET/CT: Lymph Nodes	4.0	2.0	4.0	2.0	6.0	3.5
PET/CT: Bone	2.0	1.0	1.0	1.0	2.0	3.0
PET/CT: Lung	0.0	0.0	0.0	0.0	0.0	0.0
PET: Primary Site	1.0	1.0	1.0	0.5	1.0	1.0
PET: Liver	7.5	9.0	8.0	13.0	14.0	11.0
PET: Lymph Nodes	4.0	4.0	3.0	2.0	6.5	4.5
PET: Bone	1.0	1.0	1.0	1.0	3.5	3.0
PET: Lung	0.5	0.0	0.0	2.0	2.0	0.0

9. Secondary Outcome

Title	Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
Description	For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by both peptide mass range and radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Peptide Mass Dose Range 5-20 μg	Peptide Mass Dose Range 30-45 μg	Radioactivity Dose Range 40-80 MBq	Radioactivity Dose Range 100-140 MBq	Radioactivity Dose Range 160-200 MBq
Arm/Group Description	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).	Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Measure Participants	24	24	16	16	16
PET/CT: Primary Site	1.0	1.0	1.0	0.5	1.0
PET/CT: Liver	9.0	13.0	11.5	11.0	11.0
PET/CT: Lymph Nodes	4.5	2.0	4.0	2.0	4.0
PET/CT: Bone	1.0	1.5	3.0	1.0	1.0
PET/CT: Lung	0.0	0.0	0.0	0.0	0.0
PET: Primary Site	1.0	1.0	1.0	1.0	1.0
PET: Liver	9.0	11.0	10.0	8.0	13.0
PET: Lymph Nodes	6.0	4.0	4.0	3.5	6.0
PET: Bone	1.5	1.0	1.0	1.0	2.0
PET: Lung	0.5	0.0	0.0	0.0	2.0

10. Secondary Outcome

Title	Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
Description	For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Arm A: 5-20 μg/40-80 MBq	Arm A: 30-45 μg/100-140 MBq	Arm B: 5-20 μg/100-140 MBq	Arm B: 30-45 μg/160-200 MBq	Arm C: 5-20 μg/160-200 MBq	Arm C: 30-45 μg/40-80 MBq
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Measure Participants	8	8	8	8	8	8
PET/CT: Primary Site	0.5	0.5	0.0	0.0	0.5	0.5
PET/CT: Liver	6.0	9.0	8.0	10.0	4.0	5.5
PET/CT: Lymph Nodes	2.0	0.0	0.0	0.0	3.0	1.0
PET/CT: Bone	2.0	1.0	1.0	1.0	2.0	3.0
PET/CT: Lung	0.0	0.0	0.0	0.0	0.0	0.0
PET: Primary Site	0.5	0.5	0.5	0.0	1.0	1.0
PET: Liver	4.0	5.5	8.0	11.0	5.0	5.0
PET: Lymph Nodes	2.0	3.0	1.0	1.0	5.5	4.5
PET: Bone	1.0	1.0	1.0	1.0	3.5	3.0
PET: Lung	0.5	0.0	0.0	2.0	2.0	0.0

11. Secondary Outcome

Title	Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
Description	For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.
Time Frame	Day 1 and Days 16 to 22

Outcome Measure Data

Analysis Population Description

Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.

Arm/Group Title	Peptide Mass Dose Range 5-20 μg	Peptide Mass Dose Range 30-45 μg	Radioactivity Dose Range 40-80 MBq	Radioactivity Dose Range 100-140 MBq	Radioactivity Dose Range 160-200 MBq
Arm/Group Description	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).	Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).	Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).	Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Measure Participants	24	24	16	16	16
PET/CT: Primary Site	0.0	0.0	0.5	0.0	0.0
PET/CT: Liver	7.0	10.0	5.5	8.0	10.0
PET/CT: Lymph Nodes	2.0	1.0	2.0	0.0	1.0
PET/CT: Bone	1.0	1.5	3.0	1.0	1.0
PET/CT: Lung	0.0	0.0	0.0	0.0	0.0
PET: Primary Site	1.0	1.0	1.0	0.5	1.0
PET: Liver	6.0	6.0	4.5	6.0	8.0
PET: Lymph Nodes	4.5	3.5	4.0	2.0	5.0
PET: Bone	1.5	1.0	1.0	1.0	2.0
PET: Lung	0.0	0.0	0.0	0.0	2.0

Adverse Events

Time Frame	Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
Adverse Event Reporting Description	All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
Arm/Group Title	Arm A: 5-20 μg/40-80 MBq		Arm A: 30-45 μg/100-140 MBq		Arm B: 5-20 μg/100-140 MBq		Arm B: 30-45 μg/160-200 MBq		Arm C: 5-20 μg/160-200 MBq		Arm C: 30-45 μg/40-80 MBq		Overall
Arm/Group Description	Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).		Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).		Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).		Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).		Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.		Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).		Total number of AEs experienced across all Arms.
All Cause Mortality
	Arm A: 5-20 μg/40-80 MBq		Arm A: 30-45 μg/100-140 MBq		Arm B: 5-20 μg/100-140 MBq		Arm B: 30-45 μg/160-200 MBq		Arm C: 5-20 μg/160-200 MBq		Arm C: 30-45 μg/40-80 MBq		Overall
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/10 (0%)		0/10 (0%)		0/27 (0%)
Serious Adverse Events
	Arm A: 5-20 μg/40-80 MBq		Arm A: 30-45 μg/100-140 MBq		Arm B: 5-20 μg/100-140 MBq		Arm B: 30-45 μg/160-200 MBq		Arm C: 5-20 μg/160-200 MBq		Arm C: 30-45 μg/40-80 MBq		Overall
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/10 (0%)		0/10 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Arm A: 5-20 μg/40-80 MBq		Arm A: 30-45 μg/100-140 MBq		Arm B: 5-20 μg/100-140 MBq		Arm B: 30-45 μg/160-200 MBq		Arm C: 5-20 μg/160-200 MBq		Arm C: 30-45 μg/40-80 MBq		Overall
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/8 (25%)		4/8 (50%)		4/9 (44.4%)		6/9 (66.7%)		3/10 (30%)		5/10 (50%)		18/27 (66.7%)
Endocrine disorders
Basedow's disease	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Gastrointestinal disorders
Abdominal pain	0/8 (0%)	0	1/8 (12.5%)	1	0/9 (0%)	0	2/9 (22.2%)	2	0/10 (0%)	0	1/10 (10%)	1	4/27 (14.8%)	4
Diarrhoea	0/8 (0%)	0	0/8 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	2/27 (7.4%)	2
Constipation	0/8 (0%)	0	0/8 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Nausea	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	1/9 (11.1%)	1	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	2
Vomiting	0/8 (0%)	0	0/8 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/27 (3.7%)	1
General disorders
Administration site pain	0/8 (0%)	0	0/8 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	1/10 (10%)	1	1/10 (10%)	1	2/27 (7.4%)	3
Feeling cold	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	2/27 (7.4%)	3
Fatigue	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Injection site pain	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Non-cardiac chest pain	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Investigations
Blood potassium increased	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Blood urine present	0/8 (0%)	0	0/8 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Metabolism and nutrition disorders
Hyperglycaemia	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Hypertriglyceridaemia	1/8 (12.5%)	1	0/8 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Nervous system disorders
Dizziness	0/8 (0%)	0	0/8 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/27 (3.7%)	1
Renal and urinary disorders
Proteinuria	1/8 (12.5%)	1	2/8 (25%)	2	0/9 (0%)	0	2/9 (22.2%)	2	0/10 (0%)	0	1/10 (10%)	1	5/27 (18.5%)	6
Skin and subcutaneous tissue disorders
Alopecia	0/8 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1
Vascular disorders
Flushing	0/8 (0%)	0	1/8 (12.5%)	1	0/9 (0%)	0	0/9 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1

Limitations/Caveats

In each injected peptide/radioactivity dose combination for outcome measures 1, 3 and 6, the number of subjects with lesions in the primary site of GEP-NET, bone and lung was too small (0 to 3) to allow for a meaningful interpretation of the results. Similarly, in each category of peptide mass range and radioactivity dose range for outcome measures 2, 4 and 7, the number of subjects with lesions in bone and lung was too small (0 to 2) to allow for a meaningful interpretation of the results.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.