Clinical trial · Interventional
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
NCT05362032CI-TRIAL-00110239suspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study team paused enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Device | — | UNRESOLVED |
| Endorectal Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (endorectal MRI, MRI-targeted biopsy)
- description
- Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.
- interventionNames
- Device: Biopsy
- Procedure: Endorectal Magnetic Resonance Imaging
Primary outcomes (6)
- measure
- Successful acquisition of tissue samples (early feasibility study)
- timeFrame
- Start of procedure to end of procedure, an average of less than 1 day
- description
- Conducted with 10 subjects to demonstrate that OmnEcoil system can be used to obtain diagnostic tissue samples.
- measure
- Physician device-user scores (early feasibility study)
- timeFrame
- Start of procedure to end of procedure, an average of less than 1 day
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.