68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lesion numbers
研究概览
简要总结
As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.
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. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years < Age < 75 years
- •Various solid tumors with available histopathological findings, and have not been treated surgically.
- •Signed informed consent.
排除标准
- •patients with pregnancy
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
Part I: safety, tolerability, biodistribution and dosimetry
PET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes
干预措施: 68Ga-FAP-CHX (Drug)
Part II: diagnostic efficacy
Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG).
干预措施: 68Ga-FAP-CHX (Drug)
结局指标
主要结局
Lesion numbers
时间窗: Up to 2weeks
Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
the sensitivity of 68Ga-FAP-CHX PET/CT
时间窗: Up to 2 weeks
compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.
Human biodistribution
时间窗: From right after tracer injection to 2-hours post-injection
reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)
Human dosimetry
时间窗: From right after tracer injection to 2-hours post-injection
radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software.
Standard uptake value (SUV)
时间窗: Up to 2 weeks
Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
the accuracy of 68Ga-FAP-CHX PET/CT
时间窗: Up to 2 weeks
compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.
the specificity of 68Ga-FAP-CHX PET/CT
时间窗: Up to 2 weeks
compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.
次要结局
- Count of participants with treatment emergent adverse events(Up to 3 days)
- Expression ability of 68Ga-FAP-CHX in different types of tumors(Up to 3 days)
研究者
Weibing Miao, PhD
Director of Nuclear Medicine Department
First Affiliated Hospital of Fujian Medical University