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临床试验/NCT02992847
NCT02992847Unknown不适用

Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)

Hospices Civils de Lyon0 个研究点目标入组 160 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
主要终点
Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)

研究概览

简要总结

Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. These studies were mainly conducted in patients with primary or secondary brain tumor. Multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. In this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. The French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without injection. The purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.

研究设计

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

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

  • Clinical diagnosis of Multiple sclerosis
  • At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or Multihance)
  • Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent injection according to the OFSEP protocol

排除标准

  • Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)

结局指标

主要结局

Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)

时间窗: 12 months after last injection of contrast material for enhanced MR acquisition

Operator defined region of interest measure of signal intensity on unenhanced T1-weighted images after MR acquisition

次要结局

  • EDSS (Expanded Disability Status Scale) score(12 months after last injection of contrast material for enhanced MR acquisition)

研究者

申办方类型
Other
责任方
Sponsor

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