Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
NCT ID: NCT05882253
Last Updated: 2025-07-17
Study Results
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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RECRUITING
NA
225 participants
INTERVENTIONAL
2023-12-04
2028-04-30
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
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.
Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
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.
Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
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.
Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
Exclusion Criteria
* 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.
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Diego
OTHER
Responsible Party
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Mivchael Liss
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC20220897H
Identifier Type: -
Identifier Source: org_study_id
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