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Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate

Primary Purpose

Prostate Carcinoma

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Biopsy

Endorectal Magnetic Resonance Imaging

About this trial

This is an interventional diagnostic trial for Prostate Carcinoma

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (endorectal MRI, MRI-targeted biopsy)

Arm Description

Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.

Outcomes

Primary Outcome Measures

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.

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.

Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)

Assessed per Common Terminology Criteria for Adverse Events version 5.0.

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%.

Presence of cancer containing biopsies of dominant targets (traditional feasibility study)

Criteria for acceptance is proportion of cancer containing biopsies >= 76%.

Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)

Assessed per Common Terminology Criteria for Adverse Events version 5.0.

Secondary Outcome Measures

Full Information

NCT ID

NCT05362032

First Posted

April 21, 2022

Last Updated

September 8, 2023

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University, U.S. National Science Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05362032

Brief Title

Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate

Official Title

Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Suspended

Why Stopped

Electronics in OmnEcoil system clamp stand are undergoing electronic bench testing. Once images are successfully obtained, recruitment/enrollment will promptly resume.

Study Start Date

May 8, 2023 (Actual)

Primary Completion Date

April 26, 2025 (Anticipated)

Study Completion Date

May 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University, U.S. National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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 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: 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. (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) V. To monitor the safety of the OmnEcoil system. (Traditional Feasibility Study) EXPLORATORY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (endorectal MRI, MRI-targeted biopsy)

Arm Type

Experimental

Arm Description

Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.

Intervention Type

Device

Intervention Name(s)

Biopsy

Other Intervention Name(s)

BIOPSY_TYPE, Bx

Intervention Description

Undergo transrectal MRI-targeted biopsy

Intervention Type

Procedure

Intervention Name(s)

Endorectal Magnetic Resonance Imaging

Other Intervention Name(s)

Endorectal MRI

Intervention Description

Endorectal MRI

Primary Outcome Measure Information:

Title

Successful acquisition of tissue samples (early feasibility study)

Description

Conducted with 10 subjects to demonstrate that OmnEcoil system can be used to obtain diagnostic tissue samples.

Time Frame

Start of procedure to end of procedure, an average of less than 1 day

Title

Physician device-user scores (early feasibility study)

Description

Physician will rate device using a scale from 1 (excellent) to 5 (poor) following completion of OmnEcoil guided biopsy.

Time Frame

Start of procedure to end of procedure, an average of less than 1 day

Title

Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)

Description

Assessed per Common Terminology Criteria for Adverse Events version 5.0.

Time Frame

Up to 30 days after end of procedure

Title

Successful acquisition of diagnostic tissue samples (traditional feasibility study)

Description

Procedure success determined by pathological review establishing that the samples are adequate for diagnosis. Criteria for acceptance is success rate >= 90%.

Time Frame

Start of procedure to end of procedure, an average of less than 1 day

Title

Presence of cancer containing biopsies of dominant targets (traditional feasibility study)

Description

Criteria for acceptance is proportion of cancer containing biopsies >= 76%.

Time Frame

Start of procedure to end of procedure, an average of less than 1 day

Title

Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)

Description

Assessed per Common Terminology Criteria for Adverse Events version 5.0.

Time Frame

Up to 30 days after end of procedure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fergus V Coakley

Organizational Affiliation

OHSU Knight Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate

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