Study Results
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View full resultsBasic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2016-12-31
2018-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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
Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2
mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsy
Interventions
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Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2
mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. PSA\<50
3. Clinical stage \< cT2c
Exclusion Criteria
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
40 Years
79 Years
MALE
No
Sponsors
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Exact Imaging
INDUSTRY
Responsible Party
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Locations
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Urology of Virginia
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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2016-UHR-001
Identifier Type: -
Identifier Source: org_study_id
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