Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
NCT ID: NCT05384535
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-08-15
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Bi-parametric Screening MRI
Bi-parametric MRI to be administered to High Risk males
Bi-parametric MRI
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
Interventions
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Bi-parametric MRI
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
Eligibility Criteria
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Inclusion Criteria
2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2
3. Patient is willing to participated in prostate cancer screening
4. Patient is capable of giving informed consent
Exclusion Criteria
2. Patient has undergone a prior biopsy or prostate surgery
3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
7. The participant cannot tolerate lying flat for the study duration
40 Years
55 Years
MALE
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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Principal Investigators
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Ardeshir Rastinehad, DO
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Manish Vira, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Cynthia Knauer
Lake Success, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Cynthia Knauer
Role: primary
Monica Johnson
Role: backup
References
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Related Links
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Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
Medical Device Regulation and Overview General and Special Controls
How to Market Your Device
How to market Your Device (2)
Post Market Regulation Requirements
Other Identifiers
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21-1380
Identifier Type: -
Identifier Source: org_study_id