Actively Recruiting
Upright MRI for Prostate Cancer Screening
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-07
550
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
T
The Fonar Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.
CONDITIONS
Official Title
Upright MRI for Prostate Cancer Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men at risk of prostate cancer and have been advised to have a prostate MRI.
- Age 18 years or older.
- Fit to undergo all study procedures including ultrasound guided biopsy.
- Able to tolerate general or spinal anesthesia.
- Able to understand and willing to sign informed consent and follow the study protocol.
You will not qualify if you...
- Treated with 5-alpha-reductase inhibitors at enrollment or within 6 months prior.
- Previous prostate biopsy, prostate surgery, or prostate cancer treatment (except for benign prostatic hyperplasia or bladder obstruction treatments).
- Evidence of urinary tract infection or acute prostatitis within the last 3 months.
- Contraindications to MRI such as pacemaker, estimated GFR ≤50, or implanted cardiac defibrillator.
- Any other medical condition preventing study procedures.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Monali Fatterpekar, Ph.D.
CONTACT
C
Cristina Pasat-Karasik
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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