68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diagnostic performance
研究概览
简要总结
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.
详细描述
PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.
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
- All
- 接受健康志愿者
- 否
入选标准
- •breast cancer patients highly suggested by ultrasound or histologically confirmed;
- •68Ga-P16-093 PET/CT and 18F-FDG within two weeks;
- •signed written consent.
排除标准
- •known allergy against PSMA;
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
结局指标
主要结局
Diagnostic performance
时间窗: through study completion, an average of 1 year
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
次要结局
- standardized uptake value (SUV) of tumor(through study completion, an average of 1 year)