Glycoprotein IIb/IIIa PET/CT in Various GPIIb/IIIa-Related Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Standardized uptake value (SUV)
研究概览
简要总结
In the field of diagnosing Thrombi diseases, it is now a well established practice to inject positron-emitting tracers into the human body.
These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Currently, several research groups worldwide are engaged in developing and clinically validating their own GPIIb/IIIa imaging agents.
详细描述
This clinical research project aims to visualize abnormal tau pathology in the living human brain using [18F/68Ga]GP1 PET imaging. [18F/68Ga]GP1 is a small molcule-based tracer that offers stronger binding affinity to GPIIb/IIIa. The study primarily focuses on evaluating the safety and diagnostic efficacy of [18F/68Ga]GP1 PET imaging in human subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated thrombi (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled GPIIb/IIIa PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
排除标准
- •(i) patients with non-thrombi lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
Healthy participants
Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F/68Ga]GP1 followed by a PET/CT scan.
干预措施: 18F/68Ga-GP1 (Diagnostic Test)
Patients with thrombi
Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F/68Ga]GP1 followed by a PET/CT scan
干预措施: 18F/68Ga-GP1 (Diagnostic Test)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: 30 days
Standardized uptake value (SUV) of 18F/68Ga-GP1 for each target lesion of subject or suspected thrombi.
次要结局
- Diagnostic efficacy(30 days)
研究者
Shaobo Yao, PhD
Prof.
Tianjin Medical University