Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
研究概览
简要总结
The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.
Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.
详细描述
Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation.
All imaging results and histopathology results will be pooled and compared.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age <= 85 years
- •Karnofsky >= 80%
- •patient with indication ofr carotid endarterectomy
- •signed consent form
排除标准
- •indication for surgery other than endarterectomy <14 days
- •contraindication to surgery
- •contraindication to MRI
- •contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR<30ml/min/1.73m2)
- •pregnancy, breastfeeding
- •lack of discernment
研究组 & 干预措施
68Ga-NODAGA-RGD radiotracer
All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US.
干预措施: 68Ga-NODAGA-RGD PET/CT (Drug)
结局指标
主要结局
Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
时间窗: Within1 month of endarterectomy
The potential of each of the methods of imaging for the detection of inflammatory atheromatous plaques will be compared. For that purpose, the capacity of every criterion of primary assessment to determine the presence of an unstable plaque will be studied compared with the histopathological sample.
次要结局
- Comparison of AUC of the imaging methods(Within1 month of endarterectomy)
- Analysis of histopathological sample of endarterectomy(Within1 month of endarterectomy)
研究者
John O. Prior
Chief of Department of Nuclear Medicine
University of Lausanne Hospitals