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Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
NCT05882253 · University of California, San Diego
In plain English
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Official title
Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
* Able to provide informed consent
Exclusion Criteria:
* prior diagnosis of prostate cancer (Grade Group \>1)
* metastatic prostate cancer
* prior prostate cancer treatment
* contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued)
* inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI).
* Bilateral hip replacement
* Unable to provide informed consent.
Study design
Enrollment target: 225 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2023-12-04
Estimated completion: 2028-04
Last updated: 2025-07-17
Interventions
Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
Primary outcomes
- • RSM mapping value (Baseline to approximately 9 months)
Sponsor
University of California, San Diego · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactMichael A Liss, MD, PhD · contact · liss@health.ucsd.edu · 858-249-1240
ContactJessica Warbrick, ND · contact · jwarbrick@health.ucsd.edu · 858-249-1240
InvestigatorMichael A Liss, MD, PhD · principal_investigator, University of California, San Diego
All locations (1)
University of California, San DiegoRecruiting
La Jolla, California, United States