Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Prostate MRI in BRCA carriers
研究概览
简要总结
Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.
Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.
This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.
详细描述
To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.
- Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
- To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
- •Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
- •Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
- •Be 50 years of age or older.
排除标准
- •Claustrophobia
- •Contraindication to MRI
- •Contraindication to receiving low molecular weight MRI contrast agent
- •Previously diagnosed with prostate cancer
结局指标
主要结局
Prostate MRI in BRCA carriers
时间窗: 2 years (January 2016)
Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer
次要结局
- Prostate cancer in BRCA carriers(2 years January 2016)
研究者
Danny Vesprini, MD, MSc, FRCPC
Radiation Oncologist
Toronto Sunnybrook Regional Cancer Centre