A Phase 2 interventional study of Satoreotide trizoxetan 5-20μg and Satoreotide trizoxetan 30-45μg in Gastro-Enteropancreatic Neuroendocrine Tumor, sponsored by Ipsen. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-14.
Sponsored by Ipsen · Phase 2, Interventional, and Diagnostic
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.
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Exclusion Criteria:
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 · Drug: Satoreotide trizoxetan 30-45μg
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 · Drug: Satoreotide trizoxetan 30-45μg
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 · Drug: Satoreotide trizoxetan 30-45μg
Positron emission tomography (PET) imaging agent
Also known as: 68Ga-OPS202 5-20μg, 68Ga-IPN01070 5-20μg
Positron emission tomography (PET) imaging agent
Also known as: 68Ga-OPS202 30-45μg, 68Ga-IPN01070 30-45μg
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
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
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
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
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
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
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
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
Image Quality as Assessed by Independent Blinded Readers Quality Score
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
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
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
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
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
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
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
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
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
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
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
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
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
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).
| Milestone | 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 |
|---|---|---|---|
| Started | 8 | 10 | 11 |
| Completed | 8 | 9 | 10 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Subject missed procedure | 0 | 0 | 1 |
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.
| Ratio | 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 |
|---|---|---|---|---|---|---|
| PET/CT: All Organs | 3.6 (0.73 to 15.00) | 3.8 (1.71 to 13.50) | 2.1 (0.64 to 4.41) | 2.6 (0.82 to 5.25) | 2.7 (0.91 to 16.25) | 2.5 (0.82 to 9.75) |
| PET/CT: Primary Site | 0.8 (0.50 to 1.00) | 0.8 (0.50 to 1.00) | 0.5 (0.00 to 1.00) | 1.0 (1.00 to 1.00) | 1.0 (1.00 to 1.00) | 1.0 (1.00 to 1.00) |
| PET/CT: Liver | 2.1 (0.73 to 9.00) | 3.0 (2.00 to 8.00) | 2.9 (0.83 to 8.00) | 3.5 (1.50 to 11.00) | 2.4 (0.86 to 7.5) | 2.6 (0.76 to 5.17) |
| PET/CT: Lymph Nodes | 2.0 (1.80 to 3.00) | 2.0 (0.40 to 3.00) | 1.00 (0.00 to 8.00) | 0.9 (0.00 to 12.00) | 2.2 (1.25 to 5.00) | 1.6 (1.00 to 2.00) |
| PET/CT: Bone | — | — | 4.6 (4.6 to 4.6) | 3.6 (3.6 to 3.6) | — | — |
| PET/CT: Lung | — | — | 0.5 (0.00 to 1.00) | 1.0 (0.00 to 2.00) | — | — |
| PET: All Organs | 2.6 (0.73 to 19.00) | 3.9 (1.00 to 14.50) | 2.2 (1.00 to 4.50) | 2.6 (1.50 to 4.75) | 2.8 (0.91 to 13.50) | 2.7 (0.68 to 7.50) |
| PET: Primary Site | 0.8 (0.50 to 1.00) | 0.8 (0.50 to 1.00) | 1.0 (1.00 to 1.00) | 0.5 (0.00 to 1.00) | 1.0 (1.00 to 1.00) | 1.0 (1.00 to 1.00) |
| PET: Liver | 2.6 (0.73 to 5.00) | 3.3 (1.00 to 7.00) | 2.9 (0.67 to 7.00) | 3.4 (1.33 to 9.00) | 2.4 (0.86 to 7.00) | 2.3 (0.62 to 6.00) |
| PET: Lymph Nodes | 2.0 (1.80 to 3.00) | 2.0 (1.60 to 4.00) | 2.2 (0.50 to 10.0) | 2.0 (0.50 to 14.00) | 3.8 (1.00 to 6.00) | 3.1 (0.75 to 4.00) |
| PET: Bone | — | — | 3.6 (3.6 to 3.6) | 3.8 (3.8 to 3.8) | — | — |
| PET: Lung | — | — | 0.5 (0.00 to 1.00) | 1.5 (0.00 to 3.00) | — | — |
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.
| Ratio | 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 |
|---|---|---|---|---|---|
| PET/CT: All Organs | 2.7 (0.64 to 16.25) | 2.7 (0.82 to 13.50) | 3.1 (0.73 to 15.00) | 2.6 (0.64 to 13.50) | 2.6 (0.82 to 16.25) |
| PET/CT: Primary Site | 1.0 (0.00 to 1.00) | 1.0 (0.50 to 1.00) | 1.0 (0.50 to 1.00) | 0.8 (0.00 to 1.00) | 1.0 (1.00 to 1.00) |
| PET/CT: Liver | 2.3 (0.73 to 9.00) | 3.0 (0.76 to 11.00) | 2.2 (0.73 to 9.00) | 3.0 (0.83 to 8.00) | 2.7 (0.86 to 11.00) |
| PET/CT: Lymph Nodes | 2.0 (0.00 to 8.00) | 1.3 (0.00 to 12.00) | 2.0 (1.00 to 3.00) | 1.3 (0.00 to 8.00) | 1.3 (0.00 to 12.00) |
| PET/CT: Bone | 4.6 (4.6 to 4.6) | 3.6 (3.6 to 3.6) | — | 4.6 (4.6 to 4.6) | 3.6 (3.6 to 3.6) |
| PET/CT: Lung | 0.5 (0.00 to 1.00) | 1.0 (0.00 to 2.00) | — | 0.5 (0.00 to 1.00) | 1.0 (0.00 to 2.00) |
| PET: All Organs | 2.6 (0.73 to 19.00) | 2.8 (0.68 to 14.50) | 2.6 (0.68 to 19.00) | 2.8 (1.00 to 14.50) | 2.7 (0.91 to 13.50) |
| PET: Primary Site | 1.0 (0.50 to 1.00) | 1.0 (0.00 to 1.00) | 1.0 (0.50 to 1.00) | 1.0 (0.50 to 1.00) | 1.0 (0.00 to 1.00) |
| PET: Liver | 2.6 (0.67 to 7.00) | 2.8 (0.62 to 9.00) | 2.6 (0.62 to 6.00) | 3.3 (0.67 to 7.00) | 2.8 (0.86 to 9.00) |
| PET: Lymph Nodes | 2.3 (0.50 to 10.00) | 2.0 (0.50 to 14.00) | 2.7 (0.75 to 4.00) | 2.0 (0.50 to 10.00) | 2.2 (0.50 to 14.00) |
| PET: Bone | 3.6 (3.6 to 3.6) | 3.8 (3.8 to 3.8) | — | 3.6 (3.6 to 3.6) | 3.8 (3.8 to 3.8) |
| PET: Lung | 0.5 (0.00 to 1.00) | 1.5 (0.00 to 3.00) | — | 0.5 (0.00 to 1.00) | 1.5 (0.00 to 3.00) |
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.
| Ratio | 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 |
|---|---|---|---|---|---|---|
| Primary Site | 26.4 (7.04 to 45.84) | 17.5 (7.07 to 27.87) | 4.8 (4.57 to 33.81) | 18.1 (3.29 to 32.81) | 2.3 (2.3 to 2.3) | 2.2 (2.2 to 2.2) |
| Liver | 5.5 (3.75 to 12.88) | 4.7 (3.56 to 9.96) | 4.2 (3.10 to 24.95) | 4.2 (3.05 to 29.33) | 3.6 (2.13 to 10.75) | 4.0 (3.07 to 22.48) |
| Lymph Nodes | 7.4 (3.87 to 16.98) | 6.2 (3.22 to 13.76) | 5.1 (2.55 to 16.10) | 8.2 (1.54 to 13.70) | 5.7 (3.40 to 12.84) | 4.5 (3.50 to 18.69) |
| Bone | — | — | 12.7 (12.7 to 12.7) | 9.2 (9.2 to 9.2) | — | — |
| Lung | — | — | — | — | 1.1 (1.1 to 1.1) | — |
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.
| Ratio | 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 |
|---|---|---|---|---|---|
| Primary Site | 5.9 (2.28 to 45.84) | 7.1 (2.22 to 32.81) | 7.0 (2.22 to 45.84) | 7.1 (4.57 to 33.81) | 3.3 (2.28 to 32.81) |
| Liver | 4.1 (2.13 to 24.95) | 4.3 (3.05 to 29.33) | 4.3 (3.07 to 22.48) | 4.4 (3.10 to 24.95) | 4.1 (2.13 to 29.33) |
| Lymph Nodes | 5.5 (2.55 to 16.98) | 5.2 (1.54 to 18.69) | 4.9 (3.50 to 18.69) | 5.3 (2.55 to 16.10) | 5.7 (1.54 to 13.70) |
| Bone | 12.7 (12.7 to 12.7) | 9.2 (9.2 to 9.2) | — | 12.7 (12.7 to 12.7) | 9.2 (9.2 to 9.2) |
| Lung | 1.1 (1.1 to 1.1) | — | — | — | 1.1 (1.1 to 1.1) |
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.
| Cumulative Sum of Readers' Scores | Radioactivity Dose Range 40-80 MBq | Radioactivity Dose Range 100-140 MBq | Radioactivity Dose Range 160-200 MBq |
|---|---|---|---|
| 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 |
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.
| SUV | 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 |
|---|---|---|---|---|---|---|
| Primary Site | 90.3 (44.63 to 136.04) | 90.3 (43.34 to 137.34) | 24.5 (16.66 to 86.71) | 48.9 (11.93 to 85.78) | 14.2 (14.2 to 14.2) | 13.7 (13.7 to 13.7) |
| Liver | 24.2 (18.25 to 49.16) | 22.9 (18.01 to 59.83) | 9.5 (6.74 to 63.68) | 16.0 (9.56 to 78.43) | 12.4 (6.95 to 30.07) | 17.7 (10.62 to 30.28) |
| Lymph Nodes | 24.7 (19.52 to 40.74) | 35.7 (16.69 to 41.11) | 28.5 (9.03 to 83.06) | 27.7 (5.25 to 53.79) | 13.8 (6.08 to 21.73) | 12.7 (6.15 to 21.33) |
| Bone | — | — | 57.5 (57.5 to 57.5) | 36.5 (36.5 to 36.5) | — | — |
| Lung | — | — | — | — | 1.8 (1.8 to 1.8) | — |
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.
| SUV | 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 |
|---|---|---|---|---|---|
| Primary Site | 34.5 (14.19 to 136.04) | 43.3 (11.93 to 137.34) | 44.6 (13.67 to 136.04) | 43.3 (16.66 to 137.34) | 14.2 (11.93 to 85.78) |
| Liver | 15.6 (6.74 to 63.68) | 21.1 (9.56 to 78.43) | 20.0 (10.62 to 49.16) | 20.1 (6.74 to 63.68) | 13.3 (6.95 to 78.43) |
| Lymph Nodes | 20.6 (6.08 to 83.06) | 20.3 (5.25 to 53.79) | 20.4 (6.15 to 40.74) | 32.6 (9.03 to 83.06) | 18.6 (5.25 to 53.79) |
| Bone | 57.5 (57.5 to 57.5) | 36.5 (36.5 to 36.5) | — | 57.5 (57.5 to 57.5) | 36.5 (36.5 to 36.5) |
| Lung | 1.8 (1.8 to 1.8) | — | — | — | 1.8 (1.8 to 1.8) |
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.
| Lesions | 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 |
|---|---|---|---|---|---|---|
| PET/CT: Primary Site | 1.0 (0 to 1) | 1.0 (0 to 1) | 0.0 (0 to 1) | 0.5 (0 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) |
| PET/CT: Liver | 8.5 (3 to 15) | 12.5 (3 to 22) | 8.0 (0 to 19) | 11.0 (0 to 21) | 14.5 (3 to 71) | 14.5 (3 to 93) |
| PET/CT: Lymph Nodes | 4.0 (0 to 9) | 2.0 (0 to 6) | 4.0 (0 to 8) | 2.0 (0 to 12) | 6.0 (1 to 11) | 3.5 (1 to 10) |
| PET/CT: Bone | 2.0 (1 to 6) | 1.0 (1 to 5) | 1.0 (0 to 55) | 1.0 (1 to 43) | 2.0 (1 to 10) | 3.0 (2 to 6) |
| PET/CT: Lung | 0.0 (0 to 0) | 0.0 (0 to 0) | 0.0 (0 to 1) | 0.0 (0 to 2) | 0.0 (0 to 1) | 0.0 (0 to 0) |
| PET: Primary Site | 1.0 (0 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) | 0.5 (0 to 1) | 1.0 (1 to 1) | 1.0 (1 to 1) |
| PET: Liver | 7.5 (3 to 22) | 9.0 (3 to 23) | 8.0 (0 to 25) | 13.0 (0 to 26) | 14.0 (3 to 76) | 11.0 (3 to 78) |
| PET: Lymph Nodes | 4.0 (0 to 9) | 4.0 (0 to 10) | 3.0 (0 to 21) | 2.0 (0 to 18) | 6.5 (1 to 10) | 4.5 (1 to 8) |
| PET: Bone | 1.0 (1 to 1) | 1.0 (0 to 1) | 1.0 (0 to 43) | 1.0 (0 to 46) | 3.5 (2 to 15) | 3.0 (1 to 13) |
| PET: Lung | 0.5 (0 to 2) | 0.0 (0 to 1) | 0.0 (0 to 2) | 2.0 (0 to 4) | 2.0 (0 to 4) | 0.0 (0 to 0) |
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.
| Lesions | 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 |
|---|---|---|---|---|---|
| PET/CT: Primary Site | 1.0 (0 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) | 0.5 (0 to 1) | 1.0 (0 to 1) |
| PET/CT: Liver | 9.0 (0 to 71) | 13.0 (0 to 93) | 11.5 (3 to 93) | 11.0 (0 to 22) | 11.0 (0 to 71) |
| PET/CT: Lymph Nodes | 4.5 (0 to 11) | 2.0 (0 to 12) | 4.0 (0 to 10) | 2.0 (0 to 8) | 4.0 (0 to 12) |
| PET/CT: Bone | 1.0 (0 to 55) | 1.5 (1 to 43) | 3.0 (1 to 6) | 1.0 (0 to 55) | 1.0 (1 to 43) |
| PET/CT: Lung | 0.0 (0 to 1) | 0.0 (0 to 2) | 0.0 (0 to 0) | 0.0 (0 to 1) | 0.0 (0 to 2) |
| PET: Primary Site | 1.0 (0 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) |
| PET: Liver | 9.0 (0 to 76) | 11.0 (0 to 78) | 10.0 (3 to 78) | 8.0 (0 to 25) | 13.0 (0 to 76) |
| PET: Lymph Nodes | 6.0 (0 to 21) | 4.0 (0 to 18) | 4.0 (0 to 9) | 3.5 (0 to 21) | 6.0 (0 to 18) |
| PET: Bone | 1.5 (0 to 43) | 1.0 (0 to 46) | 1.0 (1 to 13) | 1.0 (0 to 43) | 2.0 (0 to 46) |
| PET: Lung | 0.5 (0 to 4) | 0.0 (0 to 4) | 0.0 (0 to 2) | 0.0 (0 to 2) | 2.0 (0 to 4) |
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.
| Lesions | 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 |
|---|---|---|---|---|---|---|
| PET/CT: Primary Site | 0.5 (-1 to 1) | 0.5 (-1 to 1) | 0.0 (-1 to 1) | 0.0 (0 to 1) | 0.5 (0 to 1) | 0.5 (0 to 1) |
| PET/CT: Liver | 6.0 (-3 to 13) | 9.0 (3 to 14) | 8.0 (-1 to 19) | 10.0 (0 to 21) | 4.0 (-3 to 53) | 5.5 (-5 to 75) |
| PET/CT: Lymph Nodes | 2.0 (0 to 8) | 0.0 (-3 to 4) | 0.0 (-3 to 7) | 0.0 (-2 to 11) | 3.0 (1 to 11) | 1.0 (0 to 10) |
| PET/CT: Bone | 2.0 (1 to 6) | 1.0 (1 to 5) | 1.0 (0 to 43) | 1.0 (1 to 31) | 2.0 (1 to 10) | 3.0 (2 to 6) |
| PET/CT: Lung | 0.0 (0 to 0) | 0.0 (0 to 0) | 0.0 (-1 to 1) | 0.0 (-1 to 1) | 0.0 (0 to 1) | 0.0 (0 to 0) |
| PET: Primary Site | 0.5 (-1 to 1) | 0.5 (-1 to 1) | 0.5 (0 to 1) | 0.0 (-1 to 1) | 1.0 (0 to 1) | 1.0 (0 to 1) |
| PET: Liver | 4.0 (-3 to 22) | 5.5 (0 to 21) | 8.0 (-2 to 25) | 11.0 (0 to 26) | 5.0 (-3 to 58) | 5.0 (-8 to 60) |
| PET: Lymph Nodes | 2.0 (0 to 8) | 3.0 (0 to 10) | 1.0 (-2 to 18) | 1.0 (-2 to 13) | 5.5 (0 to 8) | 4.5 (-1 to 7) |
| PET: Bone | 1.0 (1 to 1) | 1.0 (0 to 1) | 1.0 (0 to 31) | 1.0 (0 to 34) | 3.5 (2 to 15) | 3.0 (1 to 13) |
| PET: Lung | 0.5 (0 to 2) | 0.0 (0 to 1) | 0.0 (-1 to 2) | 2.0 (-1 to 4) | 2.0 (0 to 4) | 0.0 (0 to 0) |
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.
| Lesions | 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 |
|---|---|---|---|---|---|
| PET/CT: Primary Site | 0.0 (-1 to 1) | 0.0 (-1 to 1) | 0.5 (-1 to 1) | 0.0 (-1 to 1) | 0.0 (0 to 1) |
| PET/CT: Liver | 7.0 (-3 to 53) | 10.0 (-5 to 75) | 5.5 (-5 to 75) | 8.0 (-1 to 19) | 10.0 (-3 to 53) |
| PET/CT: Lymph Nodes | 2.0 (-3 to 11) | 1.0 (-3 to 11) | 2.0 (0 to 10) | 0.0 (-3 to 7) | 1.0 (-2 to 11) |
| PET/CT: Bone | 1.0 (0 to 43) | 1.5 (1 to 31) | 3.0 (1 to 6) | 1.0 (0 to 43) | 1.0 (1 to 31) |
| PET/CT: Lung | 0.0 (-1 to 1) | 0.0 (-1 to 1) | 0.0 (0 to 0) | 0.0 (-1 to 1) | 0.0 (-1 to 1) |
| PET: Primary Site | 1.0 (-1 to 1) | 1.0 (-1 to 1) | 1.0 (-1 to 1) | 0.5 (-1 to 1) | 1.0 (-1 to 1) |
| PET: Liver | 6.0 (-3 to 58) | 6.0 (-8 to 60) | 4.5 (-8 to 60) | 6.0 (-2 to 25) | 8.0 (-3 to 58) |
| PET: Lymph Nodes | 4.5 (-2 to 18) | 3.5 (-2 to 13) | 4.0 (-1 to 8) | 2.0 (-2 to 18) | 5.0 (-2 to 13) |
| PET: Bone | 1.5 (0 to 31) | 1.0 (0 to 34) | 1.0 (1 to 13) | 1.0 (0 to 31) | 2.0 (0 to 34) |
| PET: Lung | 0.0 (-1 to 4) | 0.0 (-1 to 4) | 0.0 (0 to 2) | 0.0 (-1 to 2) | 2.0 (-1 to 4) |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: 5-20 μg/40-80 MBq | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Arm A: 30-45 μg/100-140 MBq | 0/8 (0%) | 0/8 (0%) | 4/8 (50%) |
| Arm B: 5-20 μg/100-140 MBq | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| Arm B: 30-45 μg/160-200 MBq | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| Arm C: 5-20 μg/160-200 MBq | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Arm C: 30-45 μg/40-80 MBq | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Overall | 0/27 (0%) | 0/27 (0%) | 18/27 (66.7%) |
| Event | 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 |
|---|---|---|---|---|---|---|---|
| ProteinuriaRenal and urinary disorders | 1/8 | 2/8 | 0/9 | 2/9 | 0/10 | 1/10 | 5/27 |
| Abdominal painGastrointestinal disorders | 0/8 | 1/8 | 0/9 | 2/9 | 0/10 | 1/10 | 4/27 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 0/8 | 0/9 | 0/9 | 0/10 | 2/10 | 2/27 |
| HypertriglyceridaemiaMetabolism and nutrition disorders | 1/8 | 0/8 | 0/9 | 0/9 | 0/10 | 0/10 | 1/27 |
| FlushingVascular disorders | 0/8 | 1/8 | 0/9 | 0/9 | 0/10 | 0/10 | 1/27 |
| ConstipationGastrointestinal disorders | 0/8 | 0/8 | 0/9 | 1/9 | 0/10 | 0/10 | 1/27 |
| NauseaGastrointestinal disorders | 0/8 | 0/8 | 1/9 | 1/9 | 0/10 | 0/10 | 1/27 |
| Administration site painGeneral disorders | 0/8 | 0/8 | 0/9 | 1/9 | 1/10 | 1/10 | 2/27 |
| Feeling coldGeneral disorders | 0/8 | 0/8 | 1/9 | 0/9 | 1/10 | 1/10 | 2/27 |
| FatigueGeneral disorders | 0/8 | 0/8 | 1/9 | 0/9 | 0/10 | 0/10 | 1/27 |
The randomised population included all subjects randomly assigned to a dosing arm/sequence.
| Age, Categorical(Participants) | 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 |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 4 | 8 | 15 |
| >=65 years | 5 | 6 | 3 | 14 |
| Age, Continuous(years) | 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 |
|---|---|---|---|---|
| Mean | 70.5 ± 11.1 | 67.6 ± 6.4 | 60.7 ± 12.3 | 65.8 ± 10.8 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|
| Female | 2 | 6 | 2 | 10 |
| Male | 6 | 4 | 9 | 19 |
| Race (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 |
| White | 8 | 10 | 10 | 28 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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