Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer
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
- Adverse events after injection of 68Ga-FAPI-FS
研究概览
简要总结
This is a preliminary study of 68Ga-FAPI-FS PET/CT or PET/MR in patients with confirmed or suspicious pancreatic cancer. The goal is to determine the safety, biodistribution, and tumor uptake of 68Ga-FAPI-FS.
详细描述
This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will also be performed within a week.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
- •Expected survival of at least 3 months
- •Written informed consent provided for participation in the trial
- •In the opinion of investigator, willing and able to comply with required study procedures.
排除标准
- •Pregnancy or breastfeeding.
- •Severe claustrophobia.
研究组 & 干预措施
68Ga-FAPI-FS PET/CT
Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
干预措施: 68Ga-FAPI-FS PET/CT (Diagnostic Test)
结局指标
主要结局
Adverse events after injection of 68Ga-FAPI-FS
时间窗: From tracer injection to 3 hour post-injection
Adverse events will be recorded according to CTCEA v4.03
次要结局
- SUVmax of lung on 68Ga-FAPI-FS(From study completion to 1 month after completion)
- SUVmax of muscle on 68Ga-FAPI-FS(From study completion to 1 month after completion)
- SUVmax of liver on 68Ga-FAPI-FS(From study completion to 1 month after completion)
- SUVmax of normal pancreas on 68Ga-FAPI-FS(From study completion to 1 month after completion)
- SUVmax of blood pool on 68Ga-FAPI-FS(From study completion to 1 month after completion)
- SUVmax of brain on 68Ga-FAPI-FS(From study completion to 1 month after completion)
- SUVmax of tumor lesions on 68Ga-FAPI-FS(From study completion to 1 month after completion)