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临床试验/NCT01651520
NCT01651520Unknown不适用

Prognosis Value of the Neuronal Damage Detected by Positrons Emission Tomography (PET) With 11C-Flumazenil in Early Multiple Sclerosis.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
neuronal imaging

研究概览

简要总结

In this study the investigators will use PET and 11C-Flumazenil to visualize and quantify neuronal injury in the cortex and the deep gray matter of Multiple Sclerosis patients at an early stage. The investigators will follow up patients to determine the prognostic value of this neuronal injury.

详细描述

It is now well admitted that multiple sclerosis (MS), which is an inflammatory demyelinating disease of the central nervous system (CNS) is not restricted to white matter, but also involves grey matter, either the cortex or the deep grey matter. The progression of grey matter atrophy measured by MRI during disease course represents an interesting prognosis marker for long term progression, but this marker lack sensitivity and is hard to interpret at the individual level.

In the EAE animal models, an early neuronal damage has been described, characterized both by a synaptic and dendritic loss and by a neuronal apoptosis.

These data strongly suggest that the occurrence of an early neuronal damage during MS course could represent a major prognosis marker. Therefore there is a crucial need for the development of imaging techniques, aimed at visualizing and quantifying neuronal damage in early MS. To date MRI techniques are not able to specifically assess neuronal pathology in vivo.

In this prospective project we will determine the chronology of appearance and the prognosis value of the neuronal damage measured by PET with 11C-Flumazenil, concerning further grey matter atrophy progression and disability progression among a cohort of MS patients with recent onset.

Four groups of subjects will be included: i) patients with a RRMS evolving since less than 5 years (revised Mc Donald criteria, n=20); ii) patients with a RRMS evolving since more than 5 years and less than 10 years (n=20); iii) patients with a primary progressive MS (PPMS) evolving since less than 10 years (n=20); iv) Healthy volunteers matched for age and sex (2/3 matched with RRMS patients; 1/3 matched with PPMS patients).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Four groups of subjects will be included:
  • patients with a RRMS evolving since less than 5 years (revised Mc Donald criteria, n=20);
  • patients with a RRMS evolving since more than 5 years and less than 10 years (n=20);
  • patients with a primary progressive MS (PPMS) evolving since less than 10 years (n=20);
  • Healthy volunteers matched for age and sex (2/3 matched with RRMS patients; 1/3 matched with PPMS patients).

排除标准

  • Lack of social insurance
  • Pregnancy
  • Age > 55
  • Therapy with benzodiazepine

研究组 & 干预措施

Relapsing patients < 5 years

Experimental

Relapsing patients < 5 years

干预措施: PET with 11C-Flumazenil (Drug)

relapsing patients < 10 years

Experimental

relapsing patients < 10 years

干预措施: PET with 11C-Flumazenil (Drug)

primary progressive patients < 10 years

Experimental

primary progressive patients < 10 years

干预措施: PET with 11C-Flumazenil (Drug)

healthy volunteers

Other

healthy volunteers

干预措施: PET with 11C-Flumazenil (Drug)

结局指标

主要结局

neuronal imaging

时间窗: 2 years

Prognosis value of the neuronal imaging on 2 years evolution (atrophy and EDSS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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