Urology San Antonio MRI/MicroUS Comparison
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|ClinicalTrials.gov Identifier: NCT03762616|
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Diagnostic Test: Micro-ultrasound targeted biopsy Diagnostic Test: mpMRI targeted biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Sequential Assignment|
|Masking Description:||Investigator performing the micro-ultrasound biopsy will be blinded to the MRI report, and the investigator performing the MRI targeted biopsy will be blinded to the micro-ultrasound images and targets.|
|Official Title:||Urology San Antonio MRI/MicroUS Comparison|
|Actual Study Start Date :||November 28, 2018|
|Actual Primary Completion Date :||November 4, 2019|
|Actual Study Completion Date :||November 4, 2019|
|Experimental: Micro-ultrasound Targeted Biopsy||
Diagnostic Test: Micro-ultrasound targeted biopsy
Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
|Experimental: MRI Targeted Biopsy||
Diagnostic Test: mpMRI targeted biopsy
Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
- Detection Rate of Cancer [ Time Frame: At time of biopsy ]Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
- Lesion size and shape comparison [ Time Frame: At time of biopsy ]Comparison of lesion volume for matching lesions between mpMRI and micro-ultrasound (follow-up with detailed whole-mount pathology when available). Shape will also be assessed qualitatively.
- Detailed Pathology Correlation [ Time Frame: At time of biopsy ]Compare detailed pathological findings (cribriform structure, density of cancer, subtype of cancer) with imaging findings in both modalities.
- Retrospective on MRI [ Time Frame: At time of biopsy ]Identify percentage of micro-ultrasound lesions (with positive biopsy result) that can be identified retrospectively using mpMRI (requires retrospective re-reading of mpMRI sequences given list of micro-ultrasound targets)
- Retrospective on micro-ultrasound [ Time Frame: At time of biopsy ]Identify percentage of mpMRI lesions (with positive biopsy result) that can be identified retrospectively using micro-ultrasound (requires retrospective re-reading of micro-ultrasound sweeps given list of mpMRI targets)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762616
|United States, Texas|
|Urology San Antonio - Pasteur Plaza Surgery Center|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||David R Talley, MD||Urology San Antonio|