Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-MRI in Carotid Artery Atherosclerosis Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque
研究概览
简要总结
Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such, is able to identify active inflammatory sites. The investigators hypothesize that 18F-choline is also highly taken up in vulnerable plaques in comparison to the stable ones.
详细描述
Accumulation and subsequent activation of inflammatory cells in the atherosclerotic plaques play an essential role in transforming a stable plaque into a vulnerable plaque at risk to rupture. On this basis, the study aims to evaluate the diagnostic performance of 18F-choline PET in identifying ongoing inflammation within atherosclerotic plaques. The investigators hypothesize that 18F-choline PET is efficient in detecting intraplaque inflammation and identify vulnerable plaques that are prone to rupture in comparison to the stable ones.
It is likely that by correlating the inflammatory status of an atherosclerotic plaque (on 18F-choline PET) with the presence of other vulnerable plaque features (on MR imaging) would be of high clinical relevance for clinical diagnosis of vulnerable plaques.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients known with symptomatic carotid artery stenosis (≥2 mm carotid plaque on duplex ultrasound), who are scheduled in the clinical setting to undergo a carotid endarterectomy or who are referred to conservative therapy;
- •Age 18 years and older (no maximum age);
- •Informed consent by signing informed consent form regarding this study.
排除标准
- •Dementia, pregnancy, nursing mothers;
- •Serious neurological deficits at symptomatic side (hemi paralysis, complete aphasia);
- •Severe heart failure NYHA III-IV and severe pulmonary dysfunction dependent on oxygen supply;
- •Patients with contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic splinters in the eyes, vascular clips, claustrophobia, etc.).
研究组 & 干预措施
18F-choline PET-MR imaging
Intervention: 18F-choline PET-MR imaging.
Drug: 18F-choline, dosis 4 MBq/kg body-weight (maximum 360 MBq), administered intravenously as a single dose.
Procedure: dynamic and static 18F-choline PET-MR.
干预措施: 18F-choline PET-MR imaging (Drug)
结局指标
主要结局
correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque
时间窗: 1 year
• In case of carotid surgery, to correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque, as a measure of plaque inflammation and vulnerability on histology
18F-choline uptake, as marker of plaque inflammation
时间窗: 1 year
• To assess on PET the uptake of 18F-choline tracer in the symptomatic carotid artery plaque, given as Target-to-Background uptake Ratio (TBR);
sensitivity, specificity, negative predictive value of 18F-choline PET
时间窗: 1 year
• To determine the sensitivity, specificity, negative predictive value of 18F-choline PET in diagnosis of vulnerable plaques.
次要结局
- Correlation of F18-choline plaque uptake vs 18F-FDG uptake(1 year)
- Correlation of F18choline plaque uptake vs cardiovascular risk profile(1 year)
- Symptomatic vs asymptomatic F18-Choline uptake(1 year)
- Correlation of F18-Choline uptake vs other histologic plaque parameters.(1 year)
- Correlation of F18-Choline uptake vs PET and MRI parameters of atherosclerotic plaque(1 year)