Prostate CarcinomaNCT05362032
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
A study testing Biopsy and Endorectal Magnetic Resonance Imaging in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Biopsy and Endorectal Magnetic Resonance Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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)
- To monitor the safety of the OmnEcoil system. (Traditional Feasibility Study)
EXPLORATORY OBJECTIVES:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Biopsy, Endorectal Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyDevice
Also called BIOPSY_TYPE, Bx
Undergo transrectal MRI-targeted biopsy
Endorectal Magnetic Resonance ImagingProcedure or surgery
Also called Endorectal MRI
Endorectal MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (endorectal MRI, MRI-targeted biopsy) | Experimental | Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device. Receives: Device: Biopsy; Procedure: Endorectal Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of procedure to end of procedure, an average of less than 1 day
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.
Measured: Start of procedure to end of procedure, an average of less than 1 day
Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)
Assessed per Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 30 days after end of procedure
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%.
Measured: Start of procedure to end of procedure, an average of less than 1 day
Presence of cancer containing biopsies of dominant targets (traditional feasibility study)
Criteria for acceptance is proportion of cancer containing biopsies >= 76%.
Measured: Start of procedure to end of procedure, an average of less than 1 day
Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)
Assessed per Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 30 days after end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start8 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Why it stopped: Study team paused enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, U.S. National Science Foundation
- Responsible party
- Principal investigator, Fergus Coakley, OHSU Knight Cancer Institute
- Investigators
- Fergus V Coakley, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362032
- Sponsor's protocol ID
- STUDY00019964
- Other IDs
- NCI-2021-03941, STUDY00019964
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
- ClinicalTrials.gov ID
- NCT05362032
- Acronym / sponsor ID
- STUDY00019964
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study team paused enrollment
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, U.S. National Science Foundation
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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)
- To monitor the safety of the OmnEcoil system. (Traditional Feasibility Study)
EXPLORATORY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (endorectal MRI, MRI-targeted biopsy) | Experimental | Device: Biopsy, Procedure: Endorectal Magnetic Resonance ImagingPatients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo transrectal MRI-targeted biopsy | Device | Diagnostic (endorectal MRI, MRI-targeted biopsy) |
| Endorectal Magnetic Resonance ImagingAlso: Endorectal MRIEndorectal MRI | Procedure or surgery | Diagnostic (endorectal MRI, MRI-targeted biopsy) |
Primary outcome
Successful acquisition of tissue samples (early feasibility study)
Time frame: Start of procedure to end of procedure, an average of less than 1 day
Conducted with 10 subjects to demonstrate that OmnEcoil system can be used to obtain diagnostic tissue samples.
Physician device-user scores (early feasibility study)
Time frame: Start of procedure to end of procedure, an average of less than 1 day
Physician will rate device using a scale from 1 (excellent) to 5 (poor) following completion of OmnEcoil guided biopsy.
Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)
Time frame: Up to 30 days after end of procedure
Assessed per Common Terminology Criteria for Adverse Events version 5.0.
Successful acquisition of diagnostic tissue samples (traditional feasibility study)
Time frame: Start of procedure to end of procedure, an average of less than 1 day
Procedure success determined by pathological review establishing that the samples are adequate for diagnosis. Criteria for acceptance is success rate >= 90%.
Presence of cancer containing biopsies of dominant targets (traditional feasibility study)
Time frame: Start of procedure to end of procedure, an average of less than 1 day
Criteria for acceptance is proportion of cancer containing biopsies >= 76%.
Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)
Time frame: Up to 30 days after end of procedure
Assessed per Common Terminology Criteria for Adverse Events version 5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fergus V Coakley principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and Endorectal Magnetic Resonance Imaging in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful acquisition of tissue samples (early feasibility study) (time frame: Start of procedure to end of procedure, an average of less than 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.