Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT05362032
Status:
SUSPENDED
Last Update Posted:
2025-10-24
First Post:
2022-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
Status:
SUSPENDED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study team paused enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: