Upright MRI for Prostate Cancer Screening

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT03474913
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Upright MRI — DEVICE
    Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength
  • Standard MRI — DEVICE
    standard of care closed 3T MRI

Study Details

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.

Key Dates

Start date
Oct 1, 2018
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: Standard MRI first
    Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.
  • Arm: MRIs in random order
    Patients will consent to participate in the study, then do two MRIs in random order.

Primary Outcome Measure

PSA levels [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Ash Tewari, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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