Clinical trial NCT06043791: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labral Tear, Glenoid
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: Stephanie Muh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health
name: Courtney Scher, MD
role: PRINCIPAL_INVESTIGATOR
References: