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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05362032
• Other study ID #: STUDY00019964
• Secondary ID: NCI-2021-03941ST
• Status: Suspended
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: May 26, 2025

Study information

• Verified date: February 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 45
• Est. completion date: May 26, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Device:
• Biopsy
Undergo transrectal MRI-targeted biopsy

Procedure:
• Endorectal Magnetic Resonance Imaging
Endorectal MRI

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University, U.S. National Science Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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