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临床试验/EUCTR2015-001202-34-IT
EUCTR2015-001202-34-IT进行中(未招募)1 期

A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity. Correlation between [11C]-PK-11195 or [18F]-NAF PET (Positron Emission Tomography) and high field MRI (Magnetic Resonance Imaging): a synergistic effect by using a double-technique approach. - A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier

AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA0 个研究点目标入组 18 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Sex: Female and Male
  • - Age: = 18 years old
  • - Diagnosis of Multiple Sclerosis according to McDonald criteria, 2010 rev.
  • - EDSS 0-5.5
  • - Cerebral MRI with Gadolinium within two weeks the PET scanning
  • - High cortical disease activity (presence of at least 10 cortical lesions and/or epilepsy/seizures not secondary to non-MS pathology) and/or severe mnestic or executive impairment in neuropsychological tests.
  • - informed consent
  • - for [18F]-NaF-PET study, a sub-group of patients who presented seizures in the past 2 months will be chosen
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 18
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • - Co-occurring of other illness that can alter PET imaging (neoplasms, infectious disease, etc)
  • - previous brain surgery
  • - pregnancy (for women in reproductive age, a b-HCG test will be performed) or breast feeding
  • - allergy or intolerance to one or more of the drugs employed in this study

研究者

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