Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
研究概览
简要总结
This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11).
The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.
详细描述
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF).
The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.
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
- •Histopathological proven prostate adenocarcinoma
- •Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL
- •Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA
- •Ability to understand a written informed consent document and the willingness to sign it
排除标准
- •Current investigational therapy for prostate cancer
- •Unable to lie flat, still, or tolerate a PET/CT scan
研究者
Morand Piert, MD
Professor of Radiology
University of Michigan