Applicability of 3T Shoulder MRI in Detection of Labral Pathology

NCT06043791 | Withdrawn FDA Device

• 1 other identifier: 16459
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labral Tear, Glenoid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

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

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

Interventions

1.5 Tesla magnet MR arthrography RADIATION

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.

Also known as: MRI Arthrogram

Treatment

3 Tesla magnet non-contrast MRI RADIATION

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

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indicated for likely labral surgery
• Chronic, degenerative labral and/or cartilage pathology
• Ability to read and understand English
• Age ≥ 18 years
• Age ≤ 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health

Royal Oak, Michigan, 48067, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Stephanie Muh, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

• Courtney Scher, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)