A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lesions detected by 18F-FES PET/CT
研究概览
简要总结
18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed metastatic ER-positive breast cancer;
- •18F-FDG PET/CT within two weeks;
- •signed written consent.
排除标准
- •pregnancy;
- •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
Lesions detected by 18F-FES PET/CT
时间窗: through study completion, an average of 1 year
The number of target lesions was calculated by 18F-FES PET/CT.
Compared with 18F-FDG PET/CT
时间窗: through study completion, an average of 1 year
The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.
Standardized uptake value of 18F-FES in BC
时间窗: through study completion, an average of 1 year
The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
次要结局
- Overall survival(3 years)