Applicability of 3T Shoulder MRI in Detection of Labral Pathology

Labral Tear, Glenoid Clinical Trial

Official title:

Applicability of 3T Shoulder MRI in Detection of Labral Pathology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06043791
• Other study ID #: 16459
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: Julio Nerys-Figueroa, BS
• Phone: 787-605-7431
• Email: jnerys1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Labral Tear, Glenoid
• Rotator Cuff Injuries

Intervention

Radiation:
• 1.5 Tesla magnet MR arthrography
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.
• 3 Tesla magnet non-contrast MRI
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

Locations

Country	Name	City	State
United States	Henry Ford Health	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week