18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer

Stanford University1 个研究点分布在 1 个国家开始时间: 2021年3月22日最近更新: 2024年12月19日

适应症

试验速览

阶段: 不适用
状态: Approved For Marketing
发起方: Stanford University
试验地点: 1

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

详细描述

This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Patient is older than 18-year-old
•Biopsy proven prostate adenocarcinoma
•Planned prostatectomy with lymph node dissection
•Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
•Able to provide written consent
•Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

排除标准

•Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
•Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
•Metallic implants (contraindicated for MRI)

研究者

发起方

Stanford University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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