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
210 participants
INTERVENTIONAL
2022-11-30
2033-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Combined MRI and micro-ultrasound guided prostate biopsy.
In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.
High-resolution micro-ultrasound
In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.
Interventions
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High-resolution micro-ultrasound
In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Men who cannot undergo a prostate biopsy
18 Years
MALE
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Adam Kinnaird, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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University of California Los Angeles, Department of Urology
Los Angeles, California, United States
Kipnes Urology Centre - Kaye Edmonton Clinic
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, Alberta, Canada
CIUSSS du Nord-de-L'Ile-De-Montreal
Montreal, Quebec, Canada
Humanitas
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Adam Kinnaird, MD
Role: primary
Nadia
Role: backup
Other Identifiers
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HREBA.CC-22-0135
Identifier Type: -
Identifier Source: org_study_id
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