Status:
SUSPENDED
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
U.S. National Science Foundation
Conditions:
Prostate Carcinoma
Eligibility:
MALE
45+ years
Phase:
NA
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 de...
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. (Ea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05362032
Start Date
May 8 2023
End Date
July 30 2027
Last Update
October 24 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239