Urology San Antonio MRI/MicroUS Comparison

NCT03762616 | Completed Results FDA Device

• 1 other identifier: EVU-2018-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

Conditions

Prostate Cancer

Keywords

multiparametric MRI; micro-ultrasound; prostate biopsy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Cancer

  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.

  At time of biopsy

Study Arms (2)

Micro-Ultrasound Biopsy

EXPERIMENTAL

Diagnostic Test: Micro-ultrasound targeted biopsy

MRI Targeted Biopsy

EXPERIMENTAL

Diagnostic Test: mpMRI targeted biopsy

Interventions

Micro-ultrasound targeted biopsy DIAGNOSTIC_TEST

Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system

Micro-Ultrasound Biopsy

mpMRI targeted biopsy DIAGNOSTIC_TEST

Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

MRI Targeted Biopsy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
• years old
• Available mpMRI images and report, performed according to the PI-RADS v2 standard

You may not qualify if:

• Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
• Men who are unable to provide their own informed consent
• Prostate volume on MRI \> 100cc

Sponsors & Collaborators

• Exact Imaging: lead

Study Sites (1)

Urology San Antonio - Pasteur Plaza Surgery Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Due to issues with marking of targeted samples the primary endpoint was modified to distinguish between the two devices used in the arms rather than biopsy annotations.

Results Point of Contact

• Title: Dr. Brian Wodlinger
• Organization: Exact Imaging

bwodlinger@exactimaging.com

6475279032

Study Officials

• David R Talley, MD

  Urology San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 4, 2018
• Study Start: November 28, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)