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Applicability of 3T Shoulder MRI in Detection of Labral Pathology

Primary Purpose

Labral Tear, Glenoid

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1.5 Tesla magnet MR arthrography
3 Tesla magnet non-contrast MRI
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Labral Tear, Glenoid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Indicated for likely labral surgery Chronic, degenerative labral and/or cartilage pathology Ability to read and understand English Age ≥ 18 years Age ≤ 65 years Exclusion Criteria: Patient does not complete both the MR arthrogram and 3T non-contrast MRI Unexpected trauma in between the MR arthrogram and 3T non-contrast MRI Age < 18 years Age > 65 years

Sites / Locations

  • Henry Ford Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol

Outcomes

Primary Outcome Measures

Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA
Consistent diagnosis of labral tear in both imaging modalities done by fellowship-trained radiologists

Secondary Outcome Measures

Full Information

First Posted
September 12, 2023
Last Updated
October 3, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT06043791
Brief Title
Applicability of 3T Shoulder MRI in Detection of Labral Pathology
Official Title
Applicability of 3T Shoulder MRI in Detection of Labral Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this observational study is to compare image quality between 3 Tesla magnet (3T) non-contrast MRI to the current standard of MR arthrogram (1.5T magnet) in detecting shoulder labral and cartilage pathology. An orthopedic surgeon on the research team will screen for patients with high probability of labral and/or cartilaginous pathology and the need for advanced imaging. The orthopedic surgeon's inclusion of patients will be based on a thorough clinical exam and obtained history. Patients included in the study will be imaged using both protocols - the current standard of MR arthrogram with a 1.5T magnet and non-contrast imaging with a 3T magnet. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.
Detailed Description
The specific aim of this investigation is to determine the accuracy and reliability of 3T MRI in the detection of shoulder labral and cartilage pathology as compared to the current standard of MR arthrography with a 1.5T magnet scanner. Patients who present to a Henry Ford orthopedic clinic associated with a surgeon participating in this study and are indicated for labral surgery will be assessed for eligibility. Patients will be interviewed, and their medical chart reviewed to determine whether they meet inclusion and exclusion criteria. Sections of the medical chart that will be reviewed include history of present illness, medical and surgical history, and the physical exam. Patients who meet criteria for this study will be consented by the surgeon or other key study personnel. A password-protected spreadsheet stored on Henry Ford OneDrive will be used to track patients enrolled in the study and make record of patients who do not meet inclusion criteria. Patients between 14-65 years of age being seen in orthopedic clinic with shoulder pathology likely requiring surgical intervention will be screened into the study. Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol
Intervention Type
Radiation
Intervention Name(s)
1.5 Tesla magnet MR arthrography
Other Intervention Name(s)
MRI Arthrogram
Intervention Description
MR arthrogram is an invasive procedure where the patient's joint is injected with a mixture of dilute gadolinium, iodinated contrast medium, local anesthetic, and saline solution followed by imaging with 1.5 Tesla MRI.
Intervention Type
Radiation
Intervention Name(s)
3 Tesla magnet non-contrast MRI
Intervention Description
3T MRI uses very powerful magnets that produce a 3-tesla magnetic field. A 3-tesla magnetic field is twice as powerful as the fields used in conventional high-field MRI scanners, and as much as 15 times stronger than low-field or open MRI scanners. This results in a clearer and more complete image. Studies have shown that it is highly sensitive and specific in detecting labral and cartilage pathology
Primary Outcome Measure Information:
Title
Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA
Description
Consistent diagnosis of labral tear in both imaging modalities done by fellowship-trained radiologists
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Indicated for likely labral surgery Chronic, degenerative labral and/or cartilage pathology Ability to read and understand English Age ≥ 18 years Age ≤ 65 years Exclusion Criteria: Patient does not complete both the MR arthrogram and 3T non-contrast MRI Unexpected trauma in between the MR arthrogram and 3T non-contrast MRI Age < 18 years Age > 65 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Nerys-Figueroa, BS
Phone
787-605-7431
Email
jnerys1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Muh, MD
Organizational Affiliation
Henry Ford Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Courtney Scher, MD
Organizational Affiliation
Henry Ford Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Applicability of 3T Shoulder MRI in Detection of Labral Pathology

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