MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Accuracy of HM-MRI
研究概览
简要总结
The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).
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
- •Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
- •Written informed consent.
排除标准
- •Patients incapable of giving informed written consent;
- •Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
- •Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
- •Prisoners;
- •Minor children (under the age of 18 years old).
研究组 & 干预措施
Interventional Arm
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
干预措施: Diagnostic MRI (Procedure)
Interventional Arm
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
干预措施: Diagnostic Prostate Biopsy (Procedure)
Interventional Arm
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
干预措施: Risk Map DSS tool (Device)
结局指标
主要结局
Accuracy of HM-MRI
时间窗: 12 months
The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Area Under the ROC Curve (AUC) of HM-MRI
时间窗: 12 months
In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.
次要结局
- Sensitivity of HM-MRI(12 months)
- Specificity of HM-MRI(12 months)
- Positive Predictive Value (PPV) of HM-MRI(12 months)
- Negative Predictive Value (NPV) of HM-MRI(12 months)