Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- In vivo and ex vivo MRI measures data
研究概览
简要总结
Small vessel disease (SVD) accounts for 25% of strokes and is the second most common cause of dementia after Alzheimer's disease. Unlike other causes of stroke, SVD manifests itself years before the stroke by the accumulation of tissue damage. Although heterogeneous, these lesions appear on Magnetic Resonance Imaging (MRI) as white matter hypersignals (WMH). In this context, the ANR SUMMIT project will characterize these lesions in vivo to develop new markers in the early stages of stroke. It is subdivided into 4 work packages, the third one being promoted by CHRU de Tours.
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
- 年龄范围
- 82 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior Enrollement in Tours body donation program Age ≥ 82 years Able to remain supine in the MR scanner for acquisition (duration 60-minutes) Affiliation to social security Informed and written consent
排除标准
- •Contraindications to body donation, especially infectious disease (VIH, HBV…) Contraindications to MRI
研究组 & 干预措施
Healthy subjects
MRI and neuropsychological evaluation
干预措施: MRI (Device)
结局指标
主要结局
In vivo and ex vivo MRI measures data
时间窗: baseline
We will compare In vivo data: 20 MR datasets, 20 quantitative SUMMIT maps (predicted microstructure) Ex vivo data : * 3 very high-resolution MR datasets and derived quantitative microstructural maps * 18 brain samples: scanned at 17.2T by the Neurospin partner and processed with the SUMMIT method to obtain high-resolution quantitative microstructural maps * these 18 samples will be processed to get ground truth histological 3D volumes (Mircen partner). Maps of the microstructure parameters obtained from MRI (in and ex vivo) and the SUMMIT method will be quantitatively compared to histological data. This will validate the SUMMIT method at clinical (in vivo) and mesoscopic resolution (ex vivo).
次要结局
- Scores at neuropsychological evaluation(baseline)
- FLAIR and SUMMIT maps (MRI evaluation)(baseline)