Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
研究概览
简要总结
This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.
OUTLINE:
Patients undergo diffusion-weighted MRI of the pelvis.
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
- •Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:
- •Gleason >= 7
- •> 50% biopsy cores +
- •Prostate-specific antigen (PSA) >= 10
- •Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
- •No clinical or radiographic evidence for distant metastatic disease
- •In subjects with PSA < 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA > 20, a bone scan must document lack of concern for bone involvement
排除标准
- •Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
- •History of claustrophobia
- •Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
- •Unable to give written informed consent
结局指标
主要结局
Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
时间窗: Baseline
Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.
次要结局
未报告次要终点