Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
Status
RECRUITING
Phase
NA
Age
All Ages
Enrollments
225Conditions
Prostate CancerSummary
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
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.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Michael Liss, MD
- 210-567-5676
- [email protected]
Principal Investigator
- Michael A Liss, MD, PhD
Status
- RECRUITING
Contact Person
- Michael A Liss, MD, PhD
- 210-567-0548
- [email protected]
Principal Investigator
- Michael A Liss, MD, PhD
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 Plan
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)Description:
An advanced imaging software that supports improved prostate cancer detection and diagnosis
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)Description:
An advanced imaging software that supports improved prostate cancer detection and diagnosis
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)Description:
An advanced imaging software that supports improved prostate cancer detection and diagnosis
Outcome Measures
Primary Outcome Measures
RSM mapping value
Timeline
Last Updated
March 21, 2024Start Date
May 31, 2023Today
February 5, 2025Completion Date ( Estimated )
April 1, 2028
Sponsors of this trial
Lead Sponsor
The University of Texas Health Science Center at San AntonioCollaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years