Skip to main content
Clinical Trials/NCT06043791
NCT06043791
Not yet recruiting
Not Applicable

Applicability of 3T Shoulder MRI in Detection of Labral Pathology

Henry Ford Health System1 site in 1 country78 target enrollmentSeptember 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labral Tear, Glenoid
Sponsor
Henry Ford Health System
Enrollment
78
Locations
1
Primary Endpoint
Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2025
End Date
September 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Courtney Scher

Orthopedic Surgeon

Henry Ford Health System

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

Outcomes

Primary Outcomes

Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA

Time Frame: 1 week

Consistent diagnosis of labral tear in both imaging modalities done by fellowship-trained radiologists

Study Sites (1)

Loading locations...

Similar Trials