68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic value
研究概览
简要总结
As a new dual targeting PET radiotracer, 68Ga-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-Biotin in patients with various types of cancer and compared them with the results of 68Ga-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAPI.
详细描述
Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Biotin is overexpressed in various tumor cells and underexpressed in normal cells. We assume that expanding molecular probes targeting FAPI and biotin with dual targets to enhance the targeting ability of the tracer, improve the sensitivity and specificity of tumor lesion detection. 68Ga-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAPI-Biotin, and performed a head-to-head comparison with 68Ga-FAPI or 18F-FDG PET/CT scans in patients with various cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- 否
入选标准
- •Various solid tumors with available histopathological findings; Signed informed consent.
排除标准
- •Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
研究组 & 干预措施
68Ga-FAPI-Biotin PET/ CT
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI-Biotin. Tracer of 68Ga-FAPI-Biotin will be used to detect tumors by PET/CT.
干预措施: 68Ga-FAPI-Biotin (Drug)
68Ga-FAPI/18F-FDG PET/CT
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg18F-FDG. Tracer of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.
干预措施: 68Ga-FAPI/18F-FDG (Drug)
结局指标
主要结局
Diagnostic value
时间窗: through study completion, an average of 3 months.
Sensitivity and Specificity of 68Ga-FAPI-Biotin in Patients With Various Types of Cancer and compare it with 68Ga-FAPI/18F-FDG PET/CT.
次要结局
- SUV of tumors(through study completion, an average of 3 months.)