Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
Study Details
Study Description
Brief Summary
This study tests whether it is feasible to use the OmnEcoil system for transrectal 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 a multichannel needle guide for biopsy. 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 MRI procedures at two separate times.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
Early Feasibility
-
To demonstrate that the OmnEcoil system can obtain diagnostic tissue samples in vivo.
-
To collate user feedback to inform subsequent design iteration.
-
To monitor the safety of the OmnEcoil system.
Traditional Feasibility
-
To determine the performance of the OmnEcoil system, as measured by the acquisition of diagnostic tissue samples and cancer containing biopsies of target lesions.
-
To monitor the safety of the OmnEcoil system.
OUTLINE:
Patients undergo diagnostic MRI and MRI-targeted biopsy of the prostate using the OmnEcoil device.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic (endorectal MRI, MRI-targeted biopsy) Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device. |
Procedure: Biopsy
Undergo transrectal MRI-targeted biopsy
Other Names:
Procedure: Endorectal Magnetic Resonance Imaging
Endorectal MRI
Other Names:
Device: OmnEcoil
Endorectal MRI coil for use in imaging the prostate
|
Outcome Measures
Primary Outcome Measures
- Early Feasibility: Acquisition Rate of OmnEcoil tissue samples [Start of procedure to end of procedure (up to 1 day)]
Successful acquisition of diagnostic tissue samples in vivo. Criteria for acceptance: Success rate ≥ 90%.
- Early Feasibility: Physician experience using OmnEcoil system [Start of procedure to end of procedure (up to 1 day)]
Physician device-user scores (based on 1-5 scale (1 = excellent and 5 = poor) [following completion of OmnEcoil guided biopsy])
- Early Feasibility: Incidence of biopsy-related grade ≥3 adverse events (Safety of the OmnEcoil system) [Start of procedure to 30 days after end of procedure]
Incidence of biopsy-related grade ≥3 adverse events [per CTCAE v5.0]
- Traditional Feasibility: Acquisition Rate of OmnEcoil tissue samples [Start of procedure to end of procedure (up to 1 day)]
Successful acquisition of diagnostic tissue samples (procedure success). Criteria for acceptance: Success rate ≥ 90%.
- Traditional Feasibility: Proportion of cancer containing biopsies of dominant targets. [Start of procedure to end of procedure (up to 1 day)]
Determined by pathological review.
- Traditional Feasibility: Incidence of biopsy-related grade ≥3 adverse events (Safety of the OmnEcoil system) [Start of procedure to 30 days after end of procedure]
Incidence of biopsy-related grade ≥3 adverse events [per CTCAE v5.0]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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) picture archive of the hospital (PACS) 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
- U.S. National Science Foundation
- Oregon Health and Science University
Investigators
- Principal Investigator: Fergus V Coakley, OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00019964
- NCI-2021-03941
- STUDY00019964