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

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.

Study Overview

• Status: Suspended
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Device: Biopsy; Procedure: Endorectal Magnetic Resonance Imaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males, aged >= 45 years
• Willing and able to provide written informed consent, including willingness to undergo MRI-targeted biopsy using OmnEcoil investigational system
• Persistently elevated (> 3 ng/mL) or rising prostate specific antigen (PSA) level and/or abnormal digital rectal exam
• Prior negative transrectal ultrasound (TRUS) biopsy, or prior TRUS biopsy or transurethral resection of the prostate showing Gleason score =< 6 disease
• Received multiparametric prostate MRI within last 6 months prior to study enrollment with images available on Oregon Health and Science University (OHSU) image viewing system for review
• Must have at least one high-value biopsy target (i.e., score of 4 or 5 as categorized by Prostate Imaging and Reporting and Data System [PI-RADS] version 2.1) present on multiparametric MRI as evaluated by study radiologists
• Eastern Cooperative Group (ECOG) performance score 0 or 1
• Patient able to lie prone in MRI for OmnEcoil biopsy procedure

• Considered to be low bleeding risk [per Society for Interventional Radiology], including:

  • International normalized ratio (INR) <= 1.5, and
  • Platelets >= 50,000

Exclusion Criteria:

• Contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, and cardiac pacemaker)
• Any contraindication to endorectal devices and/or biopsy, including (but not limited to) severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection
• Any bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily reversed
• Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed antibiotic therapy before initiating OmnEcoil imaging/biopsy procedure
• Administration of treatment for prostate cancer such as radiation or hormonal therapy prior to MRI-targeted biopsy
• Uncontrolled intercurrent illness that would substantially increase risk of incurring adverse events (AEs), confound results, or compromise the ability of the patient to give written informed consent
• Subjects unwilling to accept a blood transfusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (endorectal MRI, MRI-targeted biopsy); Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.	Device: Biopsy; Undergo transrectal MRI-targeted biopsy; Other Names: Bx; BIOPSY_TYPE; Procedure: Endorectal Magnetic Resonance Imaging; Endorectal MRI; Other Names: Endorectal MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful acquisition of tissue samples (early feasibility study)	Conducted with 10 subjects to demonstrate that OmnEcoil system can be used to obtain diagnostic tissue samples.	Start of procedure to end of procedure, an average of less than 1 day
Physician device-user scores (early feasibility study)	Physician will rate device using a scale from 1 (excellent) to 5 (poor) following completion of OmnEcoil guided biopsy.	Start of procedure to end of procedure, an average of less than 1 day
Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)	Assessed per Common Terminology Criteria for Adverse Events version 5.0.	Up to 30 days after end of procedure
Successful acquisition of diagnostic tissue samples (traditional feasibility study)	Procedure success determined by pathological review establishing that the samples are adequate for diagnosis. Criteria for acceptance is success rate >= 90%.	Start of procedure to end of procedure, an average of less than 1 day
Presence of cancer containing biopsies of dominant targets (traditional feasibility study)	Criteria for acceptance is proportion of cancer containing biopsies >= 76%.	Start of procedure to end of procedure, an average of less than 1 day
Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)	Assessed per Common Terminology Criteria for Adverse Events version 5.0.	Up to 30 days after end of procedure

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; U.S. National Science Foundation
• Investigators: Principal Investigator: Fergus V Coakley, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: STUDY00019964 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-03941 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes