Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
Purpose
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
- Prostate Cancer
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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.
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 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 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. |
|
Recruiting Locations
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio, Texas 78229
San Antonio, Texas 78229
University Health System
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
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.