Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
研究概览
简要总结
Fibroblast activation protein (FAP) emerges as a highly promising target for cancer diagnostic imaging and targeted radionuclide therapy. To exploit the therapeutic potential of current FAP inhibitors (FAPIs), this study presented the design and synthesis of a series of FAPI dimers to increase tumor uptake and retention. Preclinical evaluation and a pilot clinical PET imaging study were conducted to screen the lead compound with the potential for radionuclide therapy.
详细描述
Three new FAPI dimers were synthesized by linking two quinoline-based FAPIs with different spacers. The in vitro binding affinity and preclinical small animal PET imaging of the compounds were compared with their monomeric counterparts, FAPI-04 and FAPI-46. The lead compound, 68Ga-LNC1013, was then evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Histologically and/or clinically confirmed and/or suspicious of gastrointestinal cancer.
- •Signed informed consent.
排除标准
- •breastfeeding;
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
结局指标
主要结局
SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
时间窗: 5 months
Comparison of 68Ga\]Ga-LNC1013, 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases
Number of discrepancies between [68Ga]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG PET scans
时间窗: 5 months
Compare the diagnostic performance between \[68Ga\]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG in patients with gastrointestinal cancer
次要结局
未报告次要终点