Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy
NCT ID: NCT05064111
Last Updated: 2025-12-03
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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SUSPENDED
100 participants
OBSERVATIONAL
2026-11-01
2028-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All subjects
The experimental conditions will include a standard prostate biopsy using an FDA-approved ultrasound machine with application of the experimental (non-FDA approved) image fusion software.
TRUS biopsy
The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.
Interventions
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TRUS biopsy
The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.
Eligibility Criteria
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Inclusion Criteria
2. Male - age \> 18
3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa)
4. Scheduled for TRUS biopsy for prostate lesion or mass
Exclusion Criteria
2. Female
3. Pre-existing blood dyscrasias
4. Inability to perform TRUS due to anal sphincter closure/surgery
5. Patients needing general anesthesia
6. Patients allergic to lidocaine
7. Patients allergic or unable to take antibiotics
18 Years
MALE
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Hina Arif-Tiwari, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Other Identifiers
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2012285076
Identifier Type: -
Identifier Source: org_study_id
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