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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Men at risk of prostate cancer and have been advised to have a prostate MRI.

• Age ≥ 18 years.

• Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy.

• Able to tolerate general or spinal anesthesia.

• Ability to understand and the willingness to sign a written informed consent and to comply with the protocol.

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Monali Fatterpekar, Ph.D.
monali.fatterpekar@mountsinai.org
(212) 241-0751
Backup
Cristina Pasat-Karasik
Cristina.Pasat-karasik@mountsinai.org
347-466-2783
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 550
Treatments
Standard MRI first
Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.
MRIs in random order
Patients will consent to participate in the study, then do two MRIs in random order.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai
Collaborators: The Fonar Corporation

This content was sourced from clinicaltrials.gov