Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Evaluation of rates of prostate cancer diagnosis
研究概览
简要总结
This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •No previous diagnosis of adenocarcinoma of the prostate
- •No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
- •Active urinary tract infection
排除标准
- •Prior pelvic radiotherapy
- •Prior androgen deprivation therapy
- •Evidence urinary tract infection or significant urinary retention
- •Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
- •Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)
结局指标
主要结局
Evaluation of rates of prostate cancer diagnosis
时间窗: One week after biopsy
The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.
次要结局
- Evaluation of Rate of cancer diagnosis using targeted biopsy(One week after biopsy)
研究者
Samir Taneja, MD
Co-Director, Smilow Comprehensive Prostate Cancer Center
NYU Langone Health