Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
研究概览
简要总结
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.
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 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
- •Agree to consent to the study
排除标准
- •Does not agree to consent.
研究组 & 干预措施
ExactVu Imaging
EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
- The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex)
- The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy
干预措施: ExactVu (Device)
结局指标
主要结局
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
时间窗: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
次要结局
- Prostate Cancer Border Identification Post-Prostatectomy(3 years)
- Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)(1 year and 10 months)
- Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison(1 year and 10 months)
- Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation(3 years)
研究者
Geoffrey Sonn
Associate Professor of Urology
Stanford University