Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Correlation coefficient
研究概览
简要总结
The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.
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
- •male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy
排除标准
- •unable to give informed consent
- •contraindication to MRI or MRI contrast agent
- •claustrophobia
- •renal impairment
- •prior hormonal or radiation therapy for prostate cancer
- •active prostatitis
- •moderate to severe rectal inflammation
- •previous rectal surgery
- •prostate biopsy within 4 weeks of planned MRI
研究组 & 干预措施
Single arm study
干预措施: MRI with gadofosveset and MR elastography (Other)
结局指标
主要结局
Correlation coefficient
时间窗: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).
Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference.
Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method
时间窗: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).
次要结局
未报告次要终点
研究者
Masoom Haider
Staff Radiologist
Sunnybrook Health Sciences Centre