NCT05362032

Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate that the OmnEcoil system can obtain diagnostic tissue samples in vivo. (Early Feasibility Study) II. To evaluate physician experience using OmnEcoil system. (Early Feasibility Study) III. To monitor the safety of the OmnEcoil system. (Early Feasibility Study) IV. To determine the performance of the OmnEcoil system as measured by the acquisition of diagnostic tissue samples and cancer containing biopsies of target lesions. (Traditional Feasibility Study) V. To monitor the safety of the OmnEcoil system. (Traditional Feasibility Study) EXPLORATORY OBJECTIVES: I. To evaluate participant comfort after undergoing MRI-targeted prostate biopsy using OmnEcoil. (Early and Traditional Feasibility) II. To assess the time required in the MRI scanner to perform an integrated MRI and biopsy using the OmnEcoil system. (Early and Traditional Feasibility) OUTLINE: Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DEVICE	Biopsy	Undergo transrectal MRI-targeted biopsy
PROCEDURE	Endorectal Magnetic Resonance Imaging	Endorectal MRI

Timeline

• Start date: 2023-05-08
• Primary completion: 2026-06-30
• Completion: 2027-07-30
• First posted: 2022-05-05
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study