Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | July 12, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 10, 2018 | ||
| 预计主要完成日期 | May 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion.[ Time Frame: Change from 0.5 to 1 and to 2 hours after injection on Day 1 ] Avid is defined by the blinded readers at one of the timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68GA-OPS202. Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours).[ Time Frame: Change from 0.5 to 1 and to 2 hours after injection on Day 1 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer | ||
| 正式标题 ICMJE | A Non-Randomised Phase II Study to Evaluate the Optimal Uptake Time of 68GA-OPS202 as a sstr2 Positive PET Imaging Agent in Subjects With Newly Diagnosed Breast Cancer | ||
| 简要概况 | The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions. 68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. 68Ga-OPS202 is made of two main components: 1) OPS202, 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 OPS202, can be seen in the PET scanner. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Diagnostic |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
54 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | May 31, 2019 | ||
| 预计主要完成日期 | May 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Women aged 18 years or older - Subjects with newly diagnosed (early or advanced) breast cancer - Eastern Cooperative Oncology Group (ECOG) performance status ≤2 - Adequate bone marrow, liver and renal function, with: - Calculated glomerular filtration rate (GFR): ≥45 mL/min - Albumin: >30 g/L - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤5 times upper limit of normal (ULN) - Bilirubin: ≤3xULN (3×1.1 mg/dL) - Leukocytes: ≥3x109/L, and neutrophils: ≥1x109/L - Erythrocytes: ≥3.5x1012/L - Platelets: ≥90x109/L - Signed written informed consent prior to any study-related procedures. Exclusion Criteria: - Subject with resected primary tumour - Subjects with confirmed ductal carcinoma in situ - Men with breast cancer - Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis - Subjects who have received any therapy for breast cancer - Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide - Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration - Any condition that precludes the proper performance of PET and/or CT scan: - Subjects who are not able to tolerate the CT contrast agent - Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis - Subjects unable to raise arms for prolonged imaging purposes - Subjects unable to lie still for the entire imaging time - Subjects weighing greater than 110 kg (243 lb) - Known hypersensitivity to radiolabelled NODAGA (1,4,7- triazacyclononane,1-glutaric acid 4,7 acetic acid), to Gallium-68, to somatostatin analogue peptide JR11 or to any of the excipients of 68Ga- OPS202 - History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids - Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C - Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration - Subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for 30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to 68Ga-OPS202 administration - Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including any mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude - Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus), and/or subjects treated with curative intent and free from disease for more than 5 years | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Austria | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Ipsen | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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