MRI Techniques for Shoulder Labral Tear

Overseen By Julio Nerys-Figueroa, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Trauma, Age < 18, Age > 65

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

78 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the research team or your doctor.

What data supports the effectiveness of the treatment 1.5 Tesla magnet MR arthrography and 3 Tesla magnet non-contrast MRI for shoulder labral tears?

Research shows that MRI, including 3 Tesla MRI, is sensitive and specific for detecting labral tears, meaning it can accurately identify these tears. Additionally, studies comparing different MRI techniques suggest that 3 Tesla MRI can effectively diagnose labral lesions, which supports its use in assessing shoulder labral tears. ^{1 2 3 4 5}

Is MRI for shoulder labral tear safe?

MRI techniques for shoulder labral tears, including MR arthrography, are generally safe. A case report noted that an incorrect concentration of contrast agent did not cause damage and was absorbed within 48 hours. Additionally, studies have evaluated patient pain perception and technical success, indicating a focus on safety and comfort. ^{6 7 8 9 10}

How does MRI differ from other treatments for shoulder labral tears?

MRI, especially at 3.0-T strength, offers a non-invasive way to detect shoulder labral tears with high sensitivity and specificity, unlike other treatments that may require surgery or invasive procedures. It provides detailed images of soft tissues, making it a preferred choice for diagnosing shoulder issues without the need for direct intervention. ^{1 2 11 12 13}

Research Team

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health

Courtney Scher, MD

Principal Investigator

Henry Ford Health

Eligibility Criteria

This trial is for English-speaking adults aged 18-65 who likely need labral surgery or have chronic shoulder issues. It's not for those with recent trauma or who can't complete both types of MRI scans.

Inclusion Criteria

I am likely to need surgery for a shoulder or hip labral tear.

Ability to read and understand English

I am 65 years old or younger.

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

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Imaging

Participants undergo standard of care MRI shoulder arthrogram on a 1.5T magnet

1 week

1 visit (in-person)

Follow-up Imaging

Participants return for non-contrast MRI of the shoulder on a 3T magnet

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for the consistency of labral tear diagnosis between imaging modalities

1 week

Treatment Details

Interventions

• 1.5 Tesla magnet MR arthrography
• 3 Tesla magnet non-contrast MRI

Trial Overview The study compares two MRI techniques: a standard MR arthrogram using a 1.5 Tesla magnet and a newer non-contrast method with a stronger, 3 Tesla magnet, to see which better detects shoulder damage.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance arthrography for assessing severity of glenohumeral labroligamentous lesions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity in detection of labral tears with 3.0-T MRI of the shoulder. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional isotropic shoulder MR arthrography: comparison with two-dimensional MR arthrography for the diagnosis of labral lesions at 3.0 T. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the glenoid labrum with 3-T MRI: is intraarticular contrast necessary? [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Diagnosis of superior labral lesions: comparison of noncontrast MRI with indirect MR arthrography in unexercised shoulders. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Direct shoulder magnetic resonance arthrography for superior labral anterior-to-posterior (SLAP) and Bankart lesions: investigation into the appropriate dose and level of local anesthesia. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Erroneous intra-articular injection of gadolinium solution at 0.5 mol/l concentration: a case report. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[Clinical and nuclear magnetic resonance tomography diagnosis of glenoid labrum injuries]. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

A comparison of saline and gadolinium shoulder MR arthrography to arthroscopy. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

MR arthrography of the shoulder: tolerance evaluation of four different injection techniques. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Shoulder MR arthrography: how, why, when. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Superior labral anterior posterior (SLAP) lesions of the glenoid labrum: reliability and accuracy of MR arthrography for diagnosis. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Shoulder magnetic resonance imaging. [2016]