Clinical Evaluation of 18F-FAPI-RGD PET/CT for Imaging of Fibroblast Activation Protein and Integrin avb3 in Various Tumor Types
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors
研究概览
简要总结
The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.
详细描述
The aim of this study is to evaluate, in patients with various types of tumor, the radiotracer uptake and clinical feasibility of 18F-FAPI-RGD PET/CT compared with those of 18F-FDG PET/CT. To evaluate the diagnostic performance of 18F-FAPI-RGD and 18F-FDG PET imaging, the results of the visually interpreted PET images will be compared with the histopathologic results (via surgery or biopsy), which are used as the gold standard for the final diagnosis. For patients for whom tissue diagnosis is not applicable, clinical and radiographic follow-up data will be used as the reference standard to validate the PET/CT findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with clinically suspected or diagnosed tumors
排除标准
- •Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
- •Complicated with chronic liver disease, myocardial infarction, stroke
- •Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
- •Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
结局指标
主要结局
Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors
时间窗: 1 month
Tracer uptake in normal organs (background) is quantified by SUVmean, which is delineated with a sphere that had a diameter of 1 cm (for small organs, including thyroid, salivary gland, and pancreas) to 2 cm(for other organs, including brain, heart, liver, kidney, spleen, muscle, and bone marrow) placed inside the organ parenchyma. The tumor-to background ratio (TBR) is calculated as tumor SUVmax/background SUVmean.
次要结局
未报告次要终点
研究者
Hao Wang
Associate senior physician
Sichuan Provincial People's Hospital