Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
研究概览
简要总结
Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke. Identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment. The aim of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study. Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and tissue-to-background ratio (TBR) will be measured among carotid plaques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Modified Rankin score ˃ 3
- •Contraindication to MRI
- •Renal failure (creatinine clearance by cockcroft ˂ 50 ml / min)
- •Pregnancy / Breastfeeding
- •Hypersensitivity to the active substance or excipients
研究组 & 干预措施
case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
干预措施: 18F-sodium fluoride PET/MR (Drug)
control
Patients with asymptomatic carotid plaque ≥ 50%
干预措施: 18F-sodium fluoride PET/MR (Drug)
结局指标
主要结局
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
时间窗: at day 0 in asymptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
时间窗: during the last 15 days in symptomatic patients
次要结局
- Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.(at day 0 in asymptomatic patients)
- Number of participants with histological image of intraplaque hemorrhage, and/or lipid-rich necrotic core and /or thinning/rupture of the fibrous cap in surgical patients.(during the last 15 days in symptomatic patients)
- Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)(at Day 0)
- Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.(at day 0 in asymptomatic patients)
- Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.(at day 0 in asymptomatic patients)
- Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.(at day 0 in asymptomatic patients)
- Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.(during the last 15 days in symptomatic patients)