Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
NCT05362032 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-05-04
Summary
This clinical trial tests whether it is feasible to use the OmnEcoil system for transrectal magnetic resonance imaging (MRI) to visualize and biopsy suspicious lesions in the prostate. The OmnEcoil device combines an endorectal coil (a type of wire placed within the rectum during diagnostic endorectal MRI to take better images of the prostate) with an endorectal probe. The OmnEcoil system is designed to allow for MRI to be used at the same time to image the prostate and aid in the biopsy of the suspected prostate cancer. Usually, these are performed as two separate events at two separate times.
Conditions
- Prostate Carcinoma
Interventions
- DEVICE
-
Biopsy
Undergo transrectal MRI-targeted biopsy
- PROCEDURE
-
Endorectal Magnetic Resonance Imaging
Endorectal MRI
Sponsors & Collaborators
-
Oregon Health and Science University
collaborator OTHER -
U.S. National Science Foundation
collaborator FED -
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
Fergus V Coakley · OHSU Knight Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-08
- Primary Completion
- 2027-06-30
- Completion
- 2028-07-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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