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Urology San Antonio MRI/MicroUS Comparison

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ClinicalTrials.gov Identifier: NCT03762616
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Exact Imaging

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: Micro-ultrasound targeted biopsy Diagnostic Test: mpMRI targeted biopsy Not Applicable

Detailed Description:
The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
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.
Primary Purpose: Diagnostic
Official Title: Urology San Antonio MRI/MicroUS Comparison
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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)



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
  2. 40-75 years old
  3. Available mpMRI images and report, performed according to the PI-RADS v2 standard

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Brian Wodlinger, PhD 905-415-0030 ext 204 bwodlinger@exactimaging.com

Locations
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United States, Texas
Urology San Antonio - Pasteur Plaza Surgery Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Manuel Hernandez    210-617-4416    manuel.hernandez@urologysanantonio.com   
Principal Investigator: David R Talley, MD         
Principal Investigator: Michael A White, MD         
Sponsors and Collaborators
Exact Imaging
Investigators
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Principal Investigator: David R Talley, MD Urology San Antonio

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Responsible Party: Exact Imaging
ClinicalTrials.gov Identifier: NCT03762616     History of Changes
Other Study ID Numbers: EVU-2018-001
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Exact Imaging:
multiparametric MRI
micro-ultrasound
prostate biopsy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases