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Urology of Virginia Case Series

NCT03035487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-05-15

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Exact Imaging

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2016-12-31
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035487 on ClinicalTrials.gov