MedTrace Logo

Urology San Antonio MRI/MicroUS Comparison

NCT03762616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-21

Study results available
· View outcomes & findings →

Summary

This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

Conditions

Interventions

DIAGNOSTIC_TEST

Micro-ultrasound targeted biopsy

Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system

DIAGNOSTIC_TEST

mpMRI targeted biopsy

Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

Sponsors & Collaborators

  • Exact Imaging

    lead INDUSTRY

Principal Investigators

  • David R Talley, MD · Urology San Antonio

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2019-11-04
Completion
2019-11-04
FDA Device
Yes

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 NCT03762616 on ClinicalTrials.gov