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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 29
- 试验地点
- 5
- 主要终点
- Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Satoreotide trizoxetan 5-20μg (Drug)
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.
干预措施: Satoreotide trizoxetan 30-45μg (Drug)
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.
干预措施: Satoreotide trizoxetan 5-20μg (Drug)
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.
干预措施: Satoreotide trizoxetan 30-45μg (Drug)
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.
干预措施: Satoreotide trizoxetan 5-20μg (Drug)
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.
干预措施: Satoreotide trizoxetan 30-45μg (Drug)
结局指标
主要结局
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
时间窗: 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.
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
时间窗: 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.
次要结局
- Image Quality as Assessed by Independent Blinded Readers Quality Score(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(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(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(Day 1 and Days 16 to 22)
- Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges(Day 1 and Days 16 to 22)
- Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges(Day 1 and Days 16 to 22)
- Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges(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(Day 1 and Days 16 to 22)
- Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges(Day 1 and Days 16 to 22)