NCT05882253

Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)	An advanced imaging software that supports improved prostate cancer detection and diagnosis

Timeline

• Start date: 2023-12-04
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2023-05-31
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States