Prostate Cancer Clinical Trial
Official title:
Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.
A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial. The aims of the study are as follows: Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial. Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model. ;
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