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

NCT05362032 | Suspended DMC FDA Device

• 2 other identifiers: STUDY00019964NCI-2021-03941
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Diagnostic (endorectal MRI, MRI-targeted biopsy)

EXPERIMENTAL

Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.

Device: Biopsy; Procedure: Endorectal Magnetic Resonance Imaging

Interventions

Biopsy DEVICE

Undergo transrectal MRI-targeted biopsy

Also known as: BIOPSY_TYPE, Bx

Diagnostic (endorectal MRI, MRI-targeted biopsy)

Endorectal Magnetic Resonance Imaging PROCEDURE

Endorectal MRI

Also known as: Endorectal MRI

Diagnostic (endorectal MRI, MRI-targeted biopsy)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• U.S. National Science Foundation: collaborator
• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fergus V Coakley

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 5, 2022
• Study Start: May 8, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)