11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Metabolism
研究概览
简要总结
RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or recurrent prostate cancer.
详细描述
OBJECTIVES:
- Measure the pharmacokinetics, whole body retention of isotope, and biodistribution of C11-methionine and FDG by PET imaging and serial sampling of blood in men with progressive prostate cancer.
- Explore metabolism of each PET scan by comparing the sensitivity of C11-methionine or FDG by PET scanning in androgen independent prostate cancer metastases with the sensitivity of C11-methionine or FDG in androgen dependent metastases on a site by site basis.
- Compare C11-methionine and FDG PET scanning to standard of care diagnostic studies which include the Tc 99m bone scan, computed tomography, and magnetic resonance imaging.
Patients fast for 6 hours prior to PET imaging with the exception of liberal water intake which is encouraged. A two way catheter is placed in the urinary bladder, and continuous isotonic saline irrigation is performed throughout scan acquisition to reduce the interference in imaging lesions in the pelvic lymph nodes and adjacent pelvic bones caused by radiation excreted in urine held in the bladder.
Each patient receives C11-methionine intravenously. PET imaging begins immediately after injection for approximately 60 minutes total using standard imaging procedures. Immediately following the completion of imaging after C11-methionine administration, each patient receives FDG intravenously. PET imaging begins approximately 45 minutes thereafter for approximately 60 minutes using standard imaging procedures.
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
- 0 Years 至 120 Years(Child, Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Metabolism
时间窗: 3 years
Percentage of Unbiopsied Lesions That Are Confirmed Positive
时间窗: 3 years
Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods
Overall Survival
时间窗: Up to 9 years
次要结局
未报告次要终点
