18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Dosimetry of normal organs and tumors
研究概览
简要总结
As a new dual targeting PET radiotracer, 18F-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 18F-FAPI-Biotin in patients with various types of cancer and compared them with the results of 18F-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 18F-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. 18F-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 18F-FAPI-Biotin, and performed a head-to-head comparison with 18F-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
- 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 80 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
dynamic PET scans
PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 120 minutes after injection.
干预措施: 18F-FAPIBiotin (Drug)
结局指标
主要结局
Dosimetry of normal organs and tumors
时间窗: From right after tracer injection to 120 minutes at post-injection
The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 18F-FAPI-Biotin. The dose delivered to normal organs and tumors will be recorded.
次要结局
- Incidence of Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.(up to 1 week)