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Urology of Virginia Case Series

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ClinicalTrials.gov Identifier: NCT03035487
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : March 4, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Exact Imaging

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Cancer of the PROSTATE Prostatic Neoplasm Device: Ultrasound guided prostate exam using SOC ultrasound system Device: mpMRI guided prostate examination using PI-RADS v2 Device: High-resolution micro-ultrasound guided prostate biopsy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Urology of Virginia Case Series
Study Start Date : December 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound

Arms and Interventions
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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 Name: ExactVu micro-ultrasound imaging system


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03035487


Locations
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United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23452
Sponsors and Collaborators
Exact Imaging
More Information
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Responsible Party: Exact Imaging
ClinicalTrials.gov Identifier: NCT03035487    
Other Study ID Numbers: 2016-UHR-001
First Posted: January 30, 2017    Key Record Dates
Results First Posted: March 4, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases