Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quantitative in vivo-imaging of 18F-X microglial binding site as a mesure of disease activity followed up by non invasive quantification of patients using imaging modality.
研究概览
简要总结
PET imaging of activated microglia offers a tool of investigation of a range of brain diseases where neuroinflammation is a component.
Amyotrophic lateral sclerosis is the most frequent motoneuronal disease in adult.
This study was designed to explore the feasibility of molecular imaging modality by Positron Emission Tomography using 18F-X as an in vivo marker of activated microglia for the assessment of neuroinflammation in amyotrophic lateral sclerosis.
PET may help in the diagnosis of the disease and, further, may allow assessment of the efficacy of antiinflammatory treatment.
详细描述
18F-X PET will be carried out requiring arterial sampling in 2 patients suffering from ALS and 2 normal subjects in order to evaluate the 18F-X quantification.
Then simplified PET using 18F-X will be carried out in 13 patients and 13 normal subjects.
Binding potential maps showing specific binding of 18f-X will be generated for each subject.
Regional binding potential values will be calculated for anatomically defined regions of interest after coregistration to and special transformation into the subject's own MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •suffering from probable or definite form of amyotrophic lateral sclerosis according to El Escorial criteria. Spinal or bulbar site of the disease.
- •Information and signature of the written consent form
- •French Social Security registration
排除标准
- •family history of ALS
- •Riluzole treatment before the first PETscan.
- •Psychiatric disorders
- •Evolution of the disease older than 18 months
- •Antiinflammatory or antibiotic treatment in the last month
结局指标
主要结局
Quantitative in vivo-imaging of 18F-X microglial binding site as a mesure of disease activity followed up by non invasive quantification of patients using imaging modality.
时间窗: Inclusion period
次要结局
- Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS(inclusion period)
- Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis(inclusion period)