Urology of Virginia Case Series

April 30, 2019 updated by: Exact Imaging

The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.

The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).

These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.

In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial will enroll nine men with an indication for a prostate biopsy.

The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.

The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.

Procedures in the study are:

  • obtain informed consent for the subject
  • image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report
  • perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit)
  • prepare biopsy specimens for pathology
  • record all procedure details in a case report form, including pathology and mpMRI reports

The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities.

Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
  2. PSA<50
  3. Clinical stage < cT2c

Exclusion Criteria:

Patients will be excluded from being included in the investigation if any of the following is true:

  1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
  2. Men with known prostate volume (from prior imaging) of > 60cc
  3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
  4. Men who are unable to provide their own informed consent
  5. Men who have contraindications to MRI or gadolinium chelate contrast

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Micro-ultrasound

Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:

  • Low resolution transrectal ultrasound examination ("LR-TRUS")
  • Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
Device: Ultrasound guided prostate exam using SOC ultrasound system
Device: mpMRI guided prostate examination using PI-RADS v2
mpMRI guided prostate examination using standard of care MRI system
Device: High-resolution micro-ultrasound guided prostate biopsy
Other Names:
  • ExactVu micro-ultrasound imaging system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keyword Description of Each Biopsy Sample
Time Frame: For each patient, keywords will be assigned within one week following the patient's procedure.
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
For each patient, keywords will be assigned within one week following the patient's procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-UHR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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