Cuff Rotator TendinitisNCT05553535
Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence
An observational study of Cuff Rotator Tendinitis, run by Central Hospital, Nancy, France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cuff Rotator Tendinitis
- What is being tested?
- MRI
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients over 18 years old referred to our department for a suspicion of rotator cuff tendinosis
Who may be able to join
- patient referred to the imaging department for a MRI scan in case of suspicion of rotator cuff tendinosis
Who cannot join
- incomplete data sets
Trial locations and contacts
No sites are listed yet.
About this study
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…).
Read more
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.
- Conditions
- Cuff Rotator Tendinitis
- Being tested
- 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.
MRIDiagnostic test
retrospective review of shoulder MRI
| Study group | Role | What they receive |
|---|---|---|
| cases | cases of rotator cuff calcific tendinosis on imaging studies Receives: Diagnostic Test: MRI | |
| witnesses | differential diagnosis or normal cases Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcific deposits presence
presence of signal hyperintensity within the tendon on MRI ZTE sequence
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cuff Rotator TendinitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GILLET Romain, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553535
- Sponsor's protocol ID
- N°1-RCB/EUDRACT
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26347995Aydingoz 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.
PubMed 35904982
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence
- ClinicalTrials.gov ID
- NCT05553535
- Acronym / sponsor ID
- N°1-RCB/EUDRACT
- Conditions
- Cuff Rotator Tendinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 23 Sep 2022 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: MRIcases of rotator cuff calcific tendinosis on imaging studies |
| witnesses | – | Diagnostic Test: MRIdifferential diagnosis or normal cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 18 years old referred to our department for a suspicion of rotator cuff tendinosis
Key inclusion criteria (1 listed)
- patient referred to the imaging department for a MRI scan in case of suspicion of rotator cuff tendinosis
Key exclusion criteria (1 listed)
- incomplete data sets
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 |
|---|---|---|
| MRIretrospective review of shoulder MRI | Diagnostic test | cases, witnesses |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 26347995Norenberg 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.
- Background: PubMed 35904982Aydingoz 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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cuff Rotator Tendinitis, run by Central Hospital, Nancy, France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact romain gillet, MD (0680987216, romain_gillet3@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553535, which also lists 2 linked publications.
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 23 Sep 2022.