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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two MRI techniques to determine which better detects shoulder issues, such as labral tears and cartilage problems. Participants will undergo both the standard MR arthrogram, which requires dye injection and uses a 1.5 Tesla magnet, and a newer non-contrast MRI with a 3 Tesla magnet. The goal is to determine if the non-contrast MRI can be as effective without dye. The study seeks participants likely to need labral surgery and who have ongoing shoulder problems. As an unphased trial, it offers participants the opportunity to contribute to advancements in MRI technology for shoulder diagnostics.

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 prior data suggests that these MRI techniques are safe for detecting shoulder labral and cartilage pathology?

Research has shown that both imaging methods used in this trial are safe for people. The 1.5 Tesla magnet MR arthrography is generally safe, though some patients might experience discomfort or pain from the contrast dye injected during the procedure. Previous studies have noted this, but it is usually manageable.

For the 3 Tesla magnet non-contrast MRI, studies indicate it is also safe and does not require contrast dye. This reduces the chances of side effects compared to MR arthrography. Overall, both imaging techniques are widely used in medicine and are considered safe for identifying shoulder problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these MRI techniques because they aim to improve the detection of shoulder labral tears. Traditional methods often use 1.5 Tesla MR arthrography, which involves injecting a contrast dye into the joint. However, this study is testing a 3 Tesla non-contrast MRI, which doesn’t require any dye. This not only makes the process less invasive and more comfortable for patients, but the stronger magnet of the 3 Tesla MRI could potentially provide clearer, more detailed images, leading to better diagnosis and treatment planning.

What evidence suggests that these MRI techniques are effective for detecting shoulder labral tears?

Research has shown that MR arthrography, a type of MRI scan with contrast dye using a 1.5 Tesla magnet, effectively detects shoulder issues. It correctly identifies actual cases 88-100% of the time and rules out false ones 89-93% of the time for problems with the glenoid labrum, a part of the shoulder. This makes it quite reliable.

In this trial, participants will undergo both MR arthrography with a 1.5 Tesla magnet and a non-contrast MRI using a 3 Tesla magnet. Studies indicate that the non-contrast MRI excels at detecting labral tears, achieving 100% accuracy for tears in the front part of the labrum. This suggests that both scanning methods are strong options for identifying shoulder problems, each with distinct advantages. ^{6 7 8 9 10}

Who Is on the Research Team?

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health

Courtney Scher, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12373060/

Role of Magnetic Resonance Arthrography (MRA) in the ... MRA demonstrated an excellent 98% Sn in identifying shoulder injuries and missed only one case of shoulder injury, suggesting that it can be an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3369153/

Is MRA an unnecessary expense in the management ... In detection of glenoid labrum pathology, MR arthrography (MRA) has shown sensitivities of 88-100% and specificities of 89-93%.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X16301635

MR arthrography evaluation in patients with traumatic ... The overall accuracy of MR arthrography compared with arthroscopy of the glenoid labrum lesions was 94%, sensitivity 93%, and specificity 96%.

4. ajronline.org ajronline.org/doi/10.2214/AJR.08.1097

3-T MRI of the Shoulder: Is MR Arthrography Necessary? | AJR They achieved 100% sensitivity for detection of anterior labral tears, 86% sensitivity for detection of superior labral tears, and 74% sensitivity for detection ...

5. link.springer.com link.springer.com/article/10.1007/s003300051050

MR arthrography of the shoulder: comparison of low-field ... Overall image quality was rated good in 17 (45 %) and fair in 21 (55 %) of 38 cases on the 0.2-T MR system, and good in 32 (84%) and fair in 6 (16%) of 38 cases ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3720992/

Indirect magnetic resonance arthrography of the shoulder This retrospective study shows that I-MRA is a highly accurate and sensitive method for the detection of labral tears.

7. skeletalrad.org skeletalrad.org/sites/default/files/White_Papers/SSR%20White%20Paper%20-%20Guidelines%20for%C2%A0Utilization%20and%C2%A0Performance%20of%C2%A0Direct%20MR%20Arthrography%20-%20SKR%202023.pdf

SSR White Paper - Guidelines for Utilization and ... In another study using dMRA at 1.5 T, the accu- racy for labral tears (anterior, posterior and SLAP tears) was. 92% and comparable to dMRA of the native ...

8. ajronline.org ajronline.org/doi/10.2214/AJR.10.5145

Morbidity of Direct MR Arthrography | AJR Direct MR arthrography is largely regarded to be a safe and useful procedure [1, 2]. However, the patient morbidity associated with this procedure may be highly ...

9. researchgate.net researchgate.net/publication/23933283_Pain_and_Other_Side_Effects_after_MR_Arthrography_Prospective_Evaluation_in_1085_Patients

Pain and Other Side Effects after MR Arthrography The use of intraarticular gadolinium contrast agent injection (MR-arthrogram) has been associated with adverse events such as post injection ...

10. jsesinternational.org jsesinternational.org/article/S2666-6383(25)00188-4/fulltext

Diagnostic accuracy of magnetic resonance imaging for ... Magee, T. Usefulness of unenhanced MRI and MR arthrography of the shoulder in detection of unstable labral tears. AJR Am J Roentgenol. 2015 ...