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mDixon TSE MRI Sequence And Conventional MRI Sequences In Dysimmune Orbitopathies (DDX)

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT02397109
Collaborator
(none)
294
Enrollment
1
Location
65
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor muscles and the orbital fat.

If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional contribution to the clinic, guiding the therapeutic management by detecting inflammatory lesions not found on clinical examination in 1/3 of cases.

The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal analysis oculomotor abnormalities as well as the orbital fat.

Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous fat removal.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    294 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Study Of The Agreement Between The mDixon TSE Sequence And Conventional MRI Sequences In The Evaluation Of Dysimmune Orbitopathies
    Actual Study Start Date :
    Apr 4, 2015
    Actual Primary Completion Date :
    Sep 1, 2020
    Actual Study Completion Date :
    Sep 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Assessment, by the determination of the Cohen's kappa coefficient, of the concordance between the conventional sequences (T1, T2, T2-fat-sat) and the mDIXON sequence for the diagnosis of inflammatory or non-inflammatory dysthyroid orbitopathy. [One hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient aged 18 to 90 years, suffering from thyroid dysfunction proved by clinical and laboratory tests, with a bilateral clinical dysthyroid orbitopathy and undergoing an eye MRI
    Exclusion Criteria:

    • Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)

    • Patient under guardianship

    • Patient not willing to participate.

    • Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)

    • Motion artifact on the sequences, not corrected by the repeat sequences

    • Metal artifact prohibiting the analysis of the region of interest

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondation Ophtalmologique Adolphe de Rothschild Paris Ile De France France 75019

    Sponsors and Collaborators

    • Fondation Ophtalmologique Adolphe de Rothschild

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondation Ophtalmologique Adolphe de Rothschild
    ClinicalTrials.gov Identifier:
    NCT02397109
    Other Study ID Numbers:
    • ALR_2015-1
    First Posted:
    Mar 24, 2015
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Additional relevant MeSH terms:
    Eye Diseases
    Graves Ophthalmopathy

    Study Results

    No Results Posted as of May 27, 2021