Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence

September 22, 2022 updated by: GILLET Romain, Central Hospital, Nancy, France

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients over 18 years old referred to our department for a suspicion of rotator cuff tendinosis

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Diagnostic test: MRI
retrospective review of shoulder MRI
witnesses
differential diagnosis or normal cases
Diagnostic test: MRI
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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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