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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02397109
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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
Dysthyroid Ophthalmopathies

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Study Type : Observational
Estimated Enrollment : 300 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 : April 4, 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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. [ Time Frame: One hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a dysthyroid orbitopathy undergoing a MRI

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02397109

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Contact: Augustin Lecler, MD +33 1 48 03 74 06

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Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile De France, France, 75019
Contact: Laurence Salomon, MD, PhD    +33 1 48 03 64 31   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02397109    
Other Study ID Numbers: ALR_2015-1
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases