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临床试验/NCT04707170
NCT04707170已完成不适用

MRI Exploration of Meningeal Inflammatory Disease

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2021年6月16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
302
试验地点
1
主要终点
detection of meningeal contrast enhancement with the FABIR sequence

研究概览

简要总结

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added.

The MRI of routine care includes at least the following sequences:

  • 3D T1 TFE 1.0 isotropic (2 minutes)
  • T2 TSE (2 minutes)
  • 3D FLAIR pre-injection (opt) (3 minutes)
  • 3D FLAIR post-injection (3 minutes)

As part of the research, the following sequences will be acquired:

  • FABIR pre-injection (3 minutes)
  • FABIR post-injection (3 minutes)

Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes:

  • 3D T1 TFE 1.0 isotropic (2 minutes)
  • 3D FLAIR (3 minutes)
  • FABIR (3 minutes)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patient over 18 years old
  • To benefit as part of his treatment of an MRI with injection of gadolinium
  • Express consent to participate in the study
  • Affiliate or beneficiary of a social security scheme
  • For the ancillary study to meet secondary endpoint number 5:
  • Patient over 18 years old
  • To benefit as part of his treatment of an MRI with injection of gadolinium
  • Hospitalized for an expected period of at least 48 hours after the time of inclusion
  • Express consent to participate in the study
  • Affiliate or beneficiary of a social security scheme

排除标准

  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

结局指标

主要结局

detection of meningeal contrast enhancement with the FABIR sequence

时间窗: 1 day

detection of meningeal contrast enhancement with the flair sequence

时间窗: 1 DAY

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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