Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
- Conditions
- Prostate Cancer
- Interventions
- Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
- Registration Number
- NCT05882253
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 225
- Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
- Able to provide informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRI imaging using General Electric (GE) MRI Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-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. MRI imaging using Phillips MRI Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-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. MRI imaging using Siemens MRI Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University Health System
🇺🇸San Antonio, Texas, United States
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
🇺🇸San Antonio, Texas, United States
Audie Murphie VA
🇺🇸San Antonio, Texas, United States