Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- SUV (Standardized Uptake Value)
研究概览
简要总结
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy
详细描述
The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.
A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.
The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.
Specific questions to be addressed:
- What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
- How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?
- What is the optimal imaging protocol in terms of imaging time after injection?
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
- Male
- 接受健康志愿者
- 否
入选标准
- •recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)
排除标准
- •< 18 years old
- •claustrophobic patients
研究组 & 干预措施
Sodium Acetate C11 PET Imaging
干预措施: Sodium Acetate C11 (Drug)
结局指标
主要结局
SUV (Standardized Uptake Value)
时间窗: Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
次要结局
- PSA (prostate specific antigen)(Every 3 - 6 months for 24 months after PET imaging)
研究者
Fabio Almeida MD
Fabio Almeida MD, Medical Director
Phoenix Molecular Imaging