NCT03035487

Urology of Virginia Case Series

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Exact Imaging · Industry
• Sex: Male
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer
• Cancer of the PROSTATE
• Prostatic Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-01
• Primary completion: 2016-12-01
• Completion: 2018-02-01
• First posted: 2017-01-30
• Last updated: 2019-05-15
• Results posted: 2019-03-04

Locations

1 site across 1 country: United States