Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

NCT05882253 | Recruiting

• 2 other identifiers: HSC20220897HR01CA279667
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Detection of prostate cancer; software application

Outcome Measures

Primary Outcomes (1)

• RSM mapping value

  Radiologists will report a standard Prostate Imaging, Reporting, and Data System (PI-RADS) and document the RSM values associated with each lesion. Change in value will be reported from baseline to routine biopsy follow-up.

  Baseline to approximately 9 months

Study Arms (3)

MRI imaging using Siemens MRI

OTHER

Participants enrolled will undergo routine Magnetic Resonance Imaging (MRI) to obtain Restricted Spectrum Mapping (RSM). These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

MRI imaging using Phillips MRI

OTHER

Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

MRI imaging using General Electric (GE) MRI

OTHER

Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

Interventions

Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI) OTHER

An advanced imaging software that supports improved prostate cancer detection and diagnosis

Also known as: On-Q Prostate

MRI imaging using General Electric (GE) MRI; MRI imaging using Phillips MRI; MRI imaging using Siemens MRI

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
• Able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael A Liss, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Liss, MD, PhD

CONTACT

858-249-1240; liss@health.ucsd.edu

Jessica Warbrick, ND

CONTACT

858-249-1240; jwarbrick@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial. The patient will undergo the prostate MRI as standard of care. The OnQ Prostate will be acquired at the same time as the standard of care MRI at no additional cost to the subject. The MRI images will be acquired using MRI equipment manufactured by 3 different companies, depending on which facility they have their imaging performed.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)