Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,225
- 试验地点
- 1
- 主要终点
- detection rate of 68Ga-PSMA PET/CT
研究概览
简要总结
multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
详细描述
Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.
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
- •Patients with mCRPC or advanced/metastatic solid tumors;
- •Male or Female, aged >18 years;
- •Written informed consent;
- •Relapse or progression of disease on CT scan and / or MRI;
- •If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Pregnancy / Nursing;
- •Participation in another clinical trial with any investigational agents within 30 days prior to study entry
- •Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
- •inability to remain still for the entire duration of the exam
研究组 & 干预措施
68Ga-PSMA
68Ga-PSMA
干预措施: 68Ga-PSMA (Drug)
结局指标
主要结局
detection rate of 68Ga-PSMA PET/CT
时间窗: up to 36 months
the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors).
次要结局
- Lesion detection rate stratified for different lesion sites(up to 36 months)
- Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03(up to 36 months)
- Lesion detection rate stratified per tumor histotypes(up to 36 months)
- Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response;(up to 36 months)