Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation of the lesion volume changes to the microglial activity at the initial positron emission tomography imaging
研究概览
简要总结
The purpose of this study is to assess whether increased microglial activation (measured using TSPO-PET) at lesion rim is associated with more rapid lesion growth during 10 year follow up.
详细描述
Objective
To evaluate individual MS lesions and their growth during a total of 10 year follow-up after initial positron emission tomography (PET) -imaging with PK11195 or TMSX radioligands.
Background: Focal inflammatory lesions in the white and grey matter of the central nervous system represent the best characterized pathological phenomena of MS disease. Some MS lesions slowly expand over time. Neuropathological studies have detected inflammatory rim formed by activated microglia cells around some MS lesions and it has been suggested that the presence of the inflammatory rim could predict lesion expansion. Our hypothesis is that the lesions with higher TSPO or TMSX radioligand binding at the initial PET scan will expand more during the total of 10-year follow up compared to those lesions with lower radioligand binding. This longitudinal follow-up study will provide a more complete picture of the association of the innate immune cell activation, lesion growth and disease progression.
Study population: The research will recruit approximately 100 MS-patients who have taken part to our previous PET-imaging MS studies in Turku PET centre. The research interventions will consist of magnetic resonance imaging (MRI) scans, blood sampling, clinical neurological evaluation and patient-reported outcome measures (filling forms).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation to a previous PET imaging study of Airas group
- •MS diagnosis
排除标准
- •Patients with other neurodegenerative disease than MS
- •Contraindication to MR scan investigations
- •Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
结局指标
主要结局
Correlation of the lesion volume changes to the microglial activity at the initial positron emission tomography imaging
时间窗: Baseline (initial PET), 3, 5, 7 and 10 years
Correlation of the lesion volume changes in the magnetic resonance imaging to the microglial activity at the initial PET imaging
次要结局
- magnetic resonance imaging metrics(Baseline (initial PET), 3, 5, 7 and 10 years)
- Multiple Sclerosis Composite Score(Baseline (initial positron emission tomography), 3, 5, 7 and 10 years)