An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive Gastro-entero-pancreatic Neuroendocrine Tumors (GEP NET) Using Positron-emission Tomography / Computed Tomography (PET/CT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.
- •A somatostatin receptor scan with results in the previous 6 months prior to dosing day.
- •At least 1 lesion detected by the previous somatostatin receptor scan.
- •Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan.
- •Blood test results as follows (WBC: ≥ 3*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN)
- •ECG: any abnormalities have to be clarified by a cardiologist.
- •Serum creatinine: within normal limits or < 120 μmol/L for patients aged 60 years or older.
- •Calculated GFR ≥ 45 mL/min.
- •Negative pregnancy test in women capable of child-bearing.
排除标准
- •Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS
- •History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids.
- •Presence of active infection at screening or history of serious infection within the previous 6 weeks.
- •Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C.
- •Any condition that precludes raised arms position for prolonged imaging purposes.
- •Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see below).
- •Therapeutic use of any somatostatin analog, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on Sandostatin® a wash-out phase of 2 days is required before the injection of the study drug.
- •Administration of another investigational medicinal product within 30 days prior to entry.
- •Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
- •Current > grade 2 toxicity from previous standard or investigational therapies, per US-NCI "Common Terminology Criteria for Adverse Events v4.0".
- •Pregnant or breast-feeding women.
- •History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
- •Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
- •Current history of malignancy; patients with a secondary tumor in remission of > 5 years can be included.
研究组 & 干预措施
68Ga-OPS202
Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses
干预措施: satoreotide trizoxetan (Drug)
结局指标
主要结局
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
时间窗: From start of IP administration to end of the study visit (approximately 28 to 36 days)
An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication
时间窗: From start of IP administration to end of the study visit (approximately 28 to 36 days)
Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.
次要结局
- The 3D-SUV-R of Malignant Lesions for Session 2(At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21)
- Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value(At 0.5, 1, 2, and 4 hour post-injection on Day 0)
- Number of Malignant and Benign Lesions Detected for Session 1(6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21)
- Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding(At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21)
- Mean SUVmax of RT for Session 2(At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21)
- Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1(6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21)
- Percent Change in 3D-SUV-R of Malignant Lesions(6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21)
- Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location(At 0.5, 1, 2, and 4 hour post-injection on Day 0)
- Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1(6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21)
- Mean SUVmax of Malignant and Benign Lesions for Session 2(At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21)
- Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1(6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21)
- Best Diagnostic Scan Assessment(At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21)