NCT02092883已完成4 期
Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Neuroinflammation in cortical and/or subcortical structures
研究概览
简要总结
The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK PET scan after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of 'cryptogenic IS'
- •Normal MRI
- •No other neurological disorder
排除标准
- •Abnormal MRI
- •No anti-inflammatory medication 48 hrs prior to PK PET scans
- •Parent/guardian unable to give written consent
研究组 & 干预措施
Infantile Spasms
Experimental
干预措施: ACTH (Drug)
结局指标
主要结局
Neuroinflammation in cortical and/or subcortical structures
时间窗: up to 6 weeks
Neuroinflammation in cortical and/or subcortical structures of the brain in patients with Infantile Spasms will be evaluated with 11-C-PK11195 PET scan at the baseline and 2 weeks after the completion of ACTH treatment (given over 4 weeks), i.e., 6 weeks after the baseline PET scan.
次要结局
未报告次要终点
研究者
Harry T Chugani
Professor
Wayne State University
研究点 (1)
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