跳至主要内容
临床试验/NCT04906941
NCT04906941已完成不适用

Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2022年1月21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
73
试验地点
1
主要终点
mean of the delta observed between the QSM of the white matter before and after injection of gadolinium

研究概览

简要总结

Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

详细描述

Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

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

  • patients over 18 years old
  • with an inflammatory CNS pathology
  • to benefit as part of care from an MRI with injection of gadolinium
  • consent to participate in the study
  • beneficiary of a social protection scheme

排除标准

  • pregnant or breastfeeding woman
  • patient benefiting from a legal protection measure
  • Patient having performed more than 3 MRI exams with gadolinium injection during his life
  • Secondary exclusion criteria :
  • motion artifact not allowing image interpretation
  • patient who has not completed one of the following sequences: T1 anatomical, FLAIR, or QSM pre-gadolinium injection.
  • Secondarily excluded patients will be replaced up to a maximum of 25 patients.

结局指标

主要结局

mean of the delta observed between the QSM of the white matter before and after injection of gadolinium

时间窗: 1 DAY

mean of the delta observed between the QSM of the white matter before and after injection of gadolinium

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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