To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.
研究概览
简要总结
MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.
详细描述
This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.
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
- •Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
- •Clinically eligible for radical prostatectomy and willing to undergo surgery
- •Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI
排除标准
- •Claustrophobia
- •Contraindication to MRI
- •Contraindication to receiving low molecular weight MRI contrast agent
- •Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
- •Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) <30ml/min
研究组 & 干预措施
Diagnostic: Single Arm
Imaging (MS3TMRI)
干预措施: MS3TMRI (Other)
结局指标
主要结局
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.
时间窗: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
Compare the targeted biopsy to the random biopsies
次要结局
- The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone(The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy)
研究者
Masoom Haider
Chief, Department of Medical Imaging
Sunnybrook Health Sciences Centre