Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer in Men Undergoing Prostate MRI
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
研究概览
简要总结
The purpose of this study is to examine if investigators can improve diagnosis of prostate cancer by using MRI/DTI?
详细描述
This is a prospective cohort study of the ability of MRI/DTI to diagnose prostate cancer in men undergoing prostate MRI.
Study design: Male adults who are scheduled to undergo MRI of the prostate, for clinical reasons, will be subjected to additional 10 minutes of image acquisition inside the MRI machine. The added MRI/DTI acquisition does not involve injection of additional contrast material. Investigators will compare between ability of the full mp-MRI images to diagnose prostate cancer to that of the MRI/DTI images
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who are scheduled to undergo MRI of the prostate at the Department of Imaging, in Beilinson Hospital, Rabin Medical Center
- •Men who are willing and able to sign an informed consent form.
排除标准
- •Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.
结局指标
主要结局
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
时间窗: 1 year
次要结局
- Compare the correlation of MRI/DTI parameters with prostate cancer diagnosis to the ones measured by mpMRI (ADC, and diffusion weighted images).(1 year)
- Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer(1 year)
- Compare between MRI/DTI and MRI in PiRAD grading(1 year)
- Compare between MRI/DTI and MRI in their ability to estimate tumor size.(1 year)
研究者
david margel
Staff Uro-Oncologist
Rabin Medical Center