Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05362032
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2022-04-21
Brief Title:
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Electronics in OmnEcoil system clamp stand are undergoing electronic bench testing Once images are successfully obtained recruitmentenrollment will promptly resume
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-03941 | REGISTRY | None | None |
| STUDY00019964 | OTHER | OHSU Knight Cancer Institute | None |