Clincosm LogoSign in Get a demo

Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05882253
Collaborator
(none)
225
Enrollment
3
Locations
3
Arms
57
Anticipated Duration (Months)
75
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
An advanced imaging software that supports improved prostate cancer detection and diagnosis
Other Names:
  • On-Q Prostate

    		•
    Other: 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.

    Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
    An advanced imaging software that supports improved prostate cancer detection and diagnosis
    Other Names:
  • On-Q Prostate

    		•
    Other: 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.

    Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
    An advanced imaging software that supports improved prostate cancer detection and diagnosis
    Other Names:
  • On-Q Prostate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. RSM mapping value [Baseline to approximately 9 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Audie Murphie VA San Antonio Texas United States 78229
    2 The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center San Antonio Texas United States 78229
    3 University Health System San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Michael A Liss, MD, PhD, University of Texas Health Science Center San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05882253
    Other Study ID Numbers:
    • HSC20220897H
    First Posted:
    May 31, 2023
    Last Update Posted:
    Jun 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The University of Texas Health Science Center at San Antonio
    Detection of prostate cancer
    software application
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jun 5, 2023