Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Performance of FAPI for lesion detection
研究概览
简要总结
The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.
Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.
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
- •Age 18 years or older
- •Able and willing to provide informed consent
- •Known diagnosis of prostate cancer
- •Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET
- •Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.
- •Willing and able to undergo PET/MRI as part of this research
排除标准
- •Unable or unwilling to provide informed consent
- •Contraindication(s) to or inability to undergo PET/MRI
- •Participants for whom PET/MRI will delay timely delivery of treatment
- •Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
- •Have their own prescription for the medication
- •The informed consent process is conducted prior to the self-administration of this medication
- •Come to the research visit with a driver
研究组 & 干预措施
Fibroblast activation protein inhibitor (FAPI)
FAPI radiotracer will be used during PET
干预措施: FAPI (Radiation)
Fibroblast activation protein inhibitor (FAPI)
FAPI radiotracer will be used during PET
干预措施: Positron Emission Tomography (PET) (Procedure)
Fibroblast activation protein inhibitor (FAPI)
FAPI radiotracer will be used during PET
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Performance of FAPI for lesion detection
时间窗: Duration of scan, up to 80 minutes
Sensitivity and specificity for lesion detection on FAPI will be compared with that of PSMA PET, using a composite reference standard (all available histology, follow up clinical/standard of care imaging, serum PSA).
Lesion FAPI uptake on PET
时间窗: Duration of scan, up to 80 minutes
FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.
Total FAPI-positive tumor volume change
时间窗: Duration of scan, up to 80 minutes
The total FAPI-positive tumor volume between pre- and post-treatment exams will be measured and compared to PSMA-response, other standard-of-care imaging response, and overall survival when available, using odds ratios for treatment response and Kaplan-Meier curve for survival.
次要结局
未报告次要终点