Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

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

Sponsor
Northwell Health
Study ID
NCT05384535
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Bi-parametric MRI — DIAGNOSTIC_TEST
    When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-parametric MRI

Study Details

To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.

Key Dates

Start date
Aug 15, 2022
Status verified
Nov 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Bi-parametric Screening MRI
    Bi-parametric MRI to be administered to High Risk males

Primary Outcome Measure

Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cynthia KnauerLake SuccessNew York11042
Cynthia Knauer
[email protected]
516-734-8500
Monica Johnson
[email protected]
516-734-8500
Ardeshir Rastinehad, DO (PRINCIPAL_INVESTIGATOR)
Manish Vira, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lake Success, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Cynthia Knauer· Lake Success, NY

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