CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Ultrasound guided prostate exam using SOC ultrasound system +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035487
NCT03035487N/ACompleted

Urology of Virginia Case Series

Exact Imaging·interventional·Posted Jan 30, 2017·Updated May 15, 2019

In Brief

A clinical study evaluating Ultrasound guided prostate exam using SOC ultrasound system, mpMRI guided prostate examination using PI-RADS v2, and 1 other intervention for Prostate Cancer and 2 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 30, 2017
Enrollment StartDec 1, 2016
Primary CompletionDec 1, 2016
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 9.4 years ago

Interventions

Ultrasound guided prostate exam using SOC ultrasound systemdevice

mpMRI guided prostate examination using PI-RADS v2device

mpMRI guided prostate examination using standard of care MRI system

High-resolution micro-ultrasound guided prostate biopsydevice