- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05553535
Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence
Conventional radiographs are still considered the reference for identifying rotator cuff calcific tendinosis.
MRI is widely performed for rotator cuff disorders evaluation but has a moderate accuracy in rotator cuff calcific tendinosis diagnosis and calcific deposits identification (sensitivity and specificity around 60%), even though it helps in determining acuity of the finding by adjacent soft tissue edema depiction and differential diagnosis identification (i.e. adhesive capsulitis, sub-acromial bursitis…).
Zero echo time (ZTE) MRI provides enhanced bone contrast by enabling the acquisition of signals from tissues exhibiting the shortest T2 values on a single sequence with a spatial resolution of 0.8-1.2 mm isotropic and can therefore provide images similar to those obtained with radiographs.
We hypothesize that ZTE images could also depict rotator cuff calcific tendinosis, but to our knowledge, no study compared this technique to radiographs and/or standard MRI.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: romain gillet, MD
- Phone Number: 0680987216
- Email: romain_gillet3@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient referred to the imaging department for a MRI scan in case of suspicion of rotator cuff tendinosis
Exclusion Criteria:
- incomplete data sets
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cases
cases of rotator cuff calcific tendinosis on imaging studies
|
retrospective review of shoulder MRI
|
witnesses
differential diagnosis or normal cases
|
retrospective review of shoulder MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
calcific deposits presence
Time Frame: Retrospective review of all MRI scans, performed at a maximum of 1 year before the reading, during two reading sessions, with an interval of 15 days, in october and november 2022
|
presence of signal hyperintensity within the tendon on MRI ZTE sequence
|
Retrospective review of all MRI scans, performed at a maximum of 1 year before the reading, during two reading sessions, with an interval of 15 days, in october and november 2022
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Norenberg D, Ebersberger HU, Walter T, Ockert B, Knobloch G, Diederichs G, Hamm B, Makowski MR. Diagnosis of Calcific Tendonitis of the Rotator Cuff by Using Susceptibility-weighted MR Imaging. Radiology. 2016 Feb;278(2):475-84. doi: 10.1148/radiol.2015150034. Epub 2015 Sep 3.
- Aydingoz U, Yildiz AE, Ergen FB. Zero Echo Time Musculoskeletal MRI: Technique, Optimization, Applications, and Pitfalls. Radiographics. 2022 Sep-Oct;42(5):1398-1414. doi: 10.1148/rg.220029. Epub 2022 Jul 29.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N°1-RCB/EUDRACT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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