RecruitingNCT03474913

Upright MRI for Prostate Cancer Screening

Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

550 participants

Start Date

Oct 1, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of MRI scans — a standard lying-down MRI and an upright MRI (where you sit or stand) — in men being evaluated for prostate cancer, to see if the upright position provides better imaging of the prostate gland. **You may be eligible if...** - You are a man aged 18 or older who is at risk for prostate cancer - Your doctor has already recommended you have a prostate MRI - You are willing and able to undergo an ultrasound-guided biopsy as part of the study - You can tolerate anesthesia if needed for the biopsy **You may NOT be eligible if...** - You have been taking 5-alpha-reductase inhibitors (medications for enlarged prostate) within the past 6 months - You have had a previous prostate biopsy, prostate surgery, or prostate cancer treatment (simple procedures for urinary symptoms are acceptable) - You have had a urinary tract infection or acute prostate infection in the past 3 months - You have a pacemaker, defibrillator, or reduced kidney function (GFR ≤50) that makes MRI unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEUpright MRI

Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

DEVICEStandard MRI

standard of care closed 3T MRI


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03474913


Related Trials