Evaluation of PSMA Expression in Triple Negative Breast Cancer Patients Using 18 F-DCFPyL-PET/CT
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Lesion detection sensitivity analysis
研究概览
简要总结
The purpose of this research is to determine the expression of Prostate Specific Membrane Antigen(PSMA) in metastatic Triple Negative Breast Cancer (TNBC) patients using Fludeoxyglucose F18 (FDG) PET/CT as the gold standard. The investigators hypothesize that most lesions in metastatic TNBC are PSMA-avid; and thus PSMA-based radionuclide therapy can be a valid treatment option for TNBC, and clinical trials can be designed for this purpose. Thirty metastatic TNBC patients will be enrolled and will be on the study for maximum of 4 weeks.
详细描述
Prostate Specific Membrane Antigen (PSMA) is not only expressed in prostate cancer and its metastases, but also it is expressed on the neovasculature of many other solid tumors including gastric, lung, adrenal, bladder and renal cell carcinomas. Also, there is evidence that breast carcinomas express PSMA, although this has not been specifically studied in the metastatic TNBC.
The study involves a total of 2 visits and on each visit, patients will undergo a PET imaging. Each patient will first undergo an (FDG) PET/CT and then in few days will undergo an 18F-DCFPyL-PET/CT. The PET scanner is a large machine with a hollow tube that will be used to see how F18 FDG is taken up into the tumor and other tissues. The patients will be asked to lie on the back on a special table that slides into the tube. The sides of the tube will be close to the body. At the first visit patients will be in this scanner for approximately 20 minutes.
The study will evaluate the expression of PSMA via 18 F-DCFPyL-PET/CT in metastatic TNBC patients and compare it with lesion detection rate of FDG PET/CT. PSMA-avid lesions will be detected using the novel agent 18 F-DCFPyL and concordance rate with FDG-avid lesions will be calculated. The standardized uptake values (SUV) of each lesion on both FDG PET/CT and 18F-DCFPyL-PET/CT will be compared to find a correlation between tumor aggressiveness (lesion SUV on FDG PET/CT) and tumor angiogenesis (lesion SUV on 18 F-DCFPyL-PET/CT).
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female >= 18 years of age
- •Patients in distantly metastatic TNBC based on the initial diagnosis biopsy.
- •Patient should have FDG positive metastatic lesions on the initial PET/CT scan performed in this study to be further included.
排除标准
- •Patients with known active other malignancy.
- •Unable to tolerate PET/CT procedure.
- •Pregnant or breastfeeding.
- •Patients with any medical condition that might compromise the safety of subject during PET acquisitions.
研究组 & 干预措施
PET Imaging of breast cancer patients
Triple negative breast cancer patients will undergo FDG PET/CT and Pyl PET/Ct
干预措施: PET imaging (Diagnostic Test)
结局指标
主要结局
Lesion detection sensitivity analysis
时间窗: 4 weeks
Comparing the sensitivity of 18 F-DCFPyL-PET/CT and FDG PET/CT in metastatic lesion detection in triple-negative breast cancer patients.
次要结局
- Quantitative radiotracer uptake analysis(4 weeks)
研究者
Ahmad Shariftabrizi
Clinical Assistant Professor
University of Iowa