Multimodal Imaging of MS Reveals the Smoldering Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 11C-PK11195 binding in MS patient brain
研究概览
简要总结
To evaluate active MS plaque evolution with conventional MRI, QSM-post processing, TSPO-PET imaging and P2X7-PET imaging.
详细描述
Objective: To establish the QSM-MRI-method as a part of MS-patient research protocol in TPC and to quantify the time and space dependent correlation of QSM-MRI signal and PET-imaging signal with both 11C-PK11195 and 11C-SMW139 radioligands in the brain of MS-patients with active disease, secondary progressive MS-patients and healthy controls.
Background: In MS brain the inflammatory lesions change over time from active to chronic active and finally to chronic inactive plaques. Conventional MRI-imaging is used to detect the lesions but it is not able to differentiate the plaque types. The most acute lesions with blood-brain-barrier defect can be identified using conventional MRI and gadolinium enhancing, but follow-up of the later plaque development with microglial activation at plaque edge is not possible using MRI. Furthermore, the diffuse microglial activation in the NAWM is not detectable with conventional MRI.
In previous studies it has been shown that chronic active plaques have a rim of active microglial cells around them. With QSM-MRI method it is possible to detect and quantify these iron containing active microglia cells around the chronic active plaque. Active microglial cells can also be detected with PET imaging and TSPO-binding radioligand 11C-PK11195 or P2X7 binding radioligand 11C-SMW139. The investigators expect that the microglial activation signals detected with QSM-MRI and PET are co-localized and that these methods would help to differentiate the plaque types and to evaluate the MS plaque evolution.
Study population: 10 MS-patients with acute gadolinium enhancing ≥0,5cm diameter lesion will be imaged at baseline and 4 and 18 months after that. For comparison 10 secondary progressive patients and 20 healthy controls will be imaged at baseline.
Methods: Clinical evaluation, brain QSM-MRI and PET imaging with 11C-PK11195 radiotracer will be performed at baseline, 4 months and 18 months. PET imaging with 11C-CSMW139 radiotracer will be performed at 4 months and 18 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
11C-PK11195 binding in MS patient brain
时间窗: Baseline, 4 months 18 months
Change in microglia-activity in MS patients during 18 months as measured by \[11C\]PK11195 PET imaging
11C-SMW139 binding in MS patient brain
时间窗: Baseline, 4 months 18 months
Change in microglia-activity in MS patients during 18 months as measured by \[11C\]SMW139 PET imaging
QSM-signal in MS patient brain
时间窗: Baseline, 4 months 18 months
Change in microglia-activity in MS patients during 18 months as measured by QSM-MRI
次要结局
- 11C-PK11195 binding in healthy control brain(Baseline)
- 11C-SMW139 binding in healthy control brain(Baseline)
- QSM-signal in healthy control brain(Baseline)
- MRI metrics(Baseline, 4 months, 18 months)
- EDSS(Baseline, 4 months, 18 months)
- MSFC(Baseline, 4 months, 18 months)
- Fatigue severity scale(Baseline, 4 months, 18 months)
- Modified Fatigue Impact Scale(Baseline, 4 months, 18 months)