Labral Tear, GlenoidNCT06043791
Applicability of 3T Shoulder MRI in Detection of Labral Pathology
A study testing 1.5 Tesla magnet MR arthrography and 3 Tesla magnet non-contrast MRI in people with Labral Tear, Glenoid, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Labral Tear, Glenoid
- What is being tested?
- 1.5 Tesla magnet MR arthrography and 3 Tesla magnet non-contrast MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indicated for likely labral surgery
- Chronic, degenerative labral and/or cartilage pathology
- Ability to read and understand English
- Age ≥ 18 years
- Age ≤ 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Labral Tear, Glenoid
- Being tested
- 1.5 Tesla magnet MR arthrography, 3 Tesla magnet non-contrast MRI
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 Tesla magnet MR arthrographyRadiation
Also called MRI Arthrogram
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 MRIRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: 1.5 Tesla magnet MR arthrography; Radiation: 3 Tesla magnet non-contrast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: We are unable to secure funding for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labral Tear, GlenoidStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Muh, MD, Principal investigator, Henry Ford HealthCourtney Scher, MD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043791
- Sponsor's protocol ID
- 16459
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of 3T Shoulder MRI in Detection of Labral Pathology
- ClinicalTrials.gov ID
- NCT06043791
- Acronym / sponsor ID
- 16459
- Conditions
- Labral Tear, Glenoid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are unable to secure funding for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: 1.5 Tesla magnet MR arthrography, Radiation: 3 Tesla magnet non-contrast MRIPatients 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indicated for likely labral surgery
- Chronic, degenerative labral and/or cartilage pathology
- Ability to read and understand English
- Age ≥ 18 years
- Age ≤ 65 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.5 Tesla magnet MR arthrographyAlso: MRI ArthrogramMR 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. | Radiation | Treatment |
| 3 Tesla magnet non-contrast MRI3T 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 | Radiation | Treatment |
Primary outcome
Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA
Time frame: 1 week
Consistent diagnosis of labral tear in both imaging modalities done by fellowship-trained radiologists
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Muh, MD principal investigator
Henry Ford Health
Courtney Scher, MD principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5 Tesla magnet MR arthrography and 3 Tesla magnet non-contrast MRI in people with Labral Tear, Glenoid, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.