Prostate Cancer Clinical Trial
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
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.
I. To demonstrate that the OmnEcoil system can obtain diagnostic tissue samples in vivo.
II. To collate user feedback to inform subsequent design iteration.
III. To monitor the safety of the OmnEcoil system.
I. To determine the performance of the OmnEcoil system, as measured by the acquisition of diagnostic tissue samples and cancer containing biopsies of target lesions.
II. To monitor the safety of the OmnEcoil system.
Patients undergo diagnostic MRI and MRI-targeted biopsy of the prostate using the OmnEcoil device.
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
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
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