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

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

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

For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by 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

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

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

Time frame: Day 1 and Days 16 to 22

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

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

Time frame: Day 1 and Days 16 to 22

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

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

Time frame: Day 1 and Days 16 to 22

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

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

Time frame: Day 1 and Days 16 to 22

Population: 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.

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

Population: 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.

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

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

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

Time frame: Day 1 and Days 16 to 22

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

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

Time frame: Day 1 and Days 16 to 22

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

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

Time frame: Day 1 and Days 16 to 22

Population: 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.