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

Study Of The Agreement Between The mDixon TSE Sequence And Conventional MRI Sequences In The Evaluation Of Dysimmune Orbitopathies

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02397109

Acronym

DDX

Enrollment

294

Registered

2015-03-24

Start date

2015-04-04

Completion date

2020-09-30

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysthyroid Ophthalmopathies

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results