跳至主要内容
临床试验/NCT02397109
NCT02397109已完成不适用

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

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2015年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: One hour

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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