Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Correlation between the value of standardized uptake value (SUV) on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination
研究概览
简要总结
Evaluating an innovative molecular imaging technique to visualize inflammation of the atherosclerotic plaque in patients with a recent ischemic stroke (<15 days) with carotid stenosis> 50%, by performing a Positron emission tomography-computed tomography (PET-CT) with PBR06 18F, a tracer for Translocator protein (TPSO).
详细描述
More than one third of cerebral ischemic events are related to an atheromatous plaque. Inflammation, through a key player, the macrophage, is associated with increased metabolic activity of atherosclerotic plaque and its possible rupture. Inflammation within the plate is thus a marker of instability. These data underscore the importance of a prospective evaluation of inflammation with specific imaging with PET tracers inflammation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Man with transient ischemic attack or recent ischemic stroke (<15j) in the carotid territory, confirmed by MRI
- •Man with carotid stenosis> 50% on the side of stroke
- •Male candidate for carotid endarterectomy
- •Subject affiliated or beneficiary of a social security scheme
- •Informed written consent
排除标准
- •Chronic inflammatory disease in progress (cancer, vasculitis, ...)
- •Patient with infection within 7 days
- •A person placed under judicial protection, guardianship
- •Incapable of giving consent
- •Low affinity binder for TSPO
研究组 & 干预措施
Experimental arm
干预措施: 18F-PBR06 (Drug)
结局指标
主要结局
Correlation between the value of standardized uptake value (SUV) on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination
时间窗: 15 days
次要结局
- Plaque parameters composite(15 days)
- Levels of leukocyte and T lymphocyte inflammation of the plaque(15 days)