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Trial Title:
Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
NCT ID:
NCT05882253
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Detection of prostate cancer
software application
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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)
Intervention:
Intervention type:
Other
Intervention name:
Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
Description:
An advanced imaging software that supports improved prostate cancer detection and
diagnosis
Arm group label:
MRI imaging using General Electric (GE) MRI
Arm group label:
MRI imaging using Phillips MRI
Arm group label:
MRI imaging using Siemens MRI
Other name:
On-Q Prostate
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.
Criteria for 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.
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Audie Murphie VA
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Michael A Liss, MD, PhD
Phone:
210-567-0548
Email:
Liss@uthscsa.edu
Contact backup:
Last name:
Brandi Weaver, BA
Phone:
210-567-0178
Email:
WeaverB@uthscsa.edu
Facility:
Name:
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Liss, MD
Phone:
210-567-5676
Email:
Liss@uthscsa.edu
Contact backup:
Last name:
Brandi Weaver, BA
Phone:
210-567-0178
Email:
WeaverB@uthscsa.edu
Investigator:
Last name:
Michael Liss, MD
Email:
Principal Investigator
Facility:
Name:
University Health System
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael A Liss, MD, PhD
Phone:
210-567-0548
Email:
Liss@uthscsa.edu
Contact backup:
Last name:
Brandi Weaver, BA
Phone:
210-567-0178
Email:
WeaverB@uthscsa.edu
Start date:
December 4, 2023
Completion date:
April 2028
Lead sponsor:
Agency:
The University of Texas Health Science Center at San Antonio
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
The University of Texas Health Science Center at San Antonio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05882253
