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
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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