Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

NCT ID: NCT05882253

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2028-04-30

Brief Summary

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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

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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

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI imaging using Siemens MRI

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.

Group Type OTHER

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

Intervention Type OTHER

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

MRI imaging using Phillips MRI

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.

Group Type OTHER

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

Intervention Type OTHER

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

MRI imaging using General Electric (GE) MRI

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.

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

Other Intervention Names

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On-Q Prostate

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Mivchael Liss

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael A Liss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael A Liss, MD, PhD

Role: CONTACT

858-249-1240

Jessica Warbrick, ND

Role: CONTACT

858-249-1240

Facility Contacts

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Michael A Liss, MD, PhD

Role: primary

858-249-1240

Jessica Warbrick, ND

Role: backup

858-249-1240

Other Identifiers

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R01CA279667

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20220897H

Identifier Type: -

Identifier Source: org_study_id

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