NCT01000181暂停不适用
A Mechanistic, Non-randomised Study to Examine the Uptake of a Specific Radionuclide (61CuATSM) in Carotid Artery Plaque
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Uptake of CuATSM in carotid plaque
研究概览
简要总结
The build up of plaque in the wall of the artery supplying blood to the brain poses a risk of stroke when the plaques become unstable and fragile. It is important to determine which patients are most at risk so that surgery can be performed. There is evidence that the risk is greatest when these plaques become oxygen deficient (hypoxic). The investigators wish to use PET imaging to identify hypoxic plaque, to help decide whether and when to perform surgery. The investigators have developed radiotracers (imaging agents) for this purpose, and this study is to determine whether they will work in patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female patients who are 55yrs or older and for whom carotid endarterectomy is clinically indicated and a decision has been made to perform a carotid endarterectomy.
- •Normal liver and adequate renal function. Assessed by measuring eGFR (>50ml/min) and creatinine (<130μmol/L)
- •Life expectancy > 12 weeks
- •Patients should be able to tolerate head/neck mask as well as lying in the PET-CT scanner
排除标准
- •Abnormal liver and renal function (eGFR <50ml/min, Creatinine >130μmol/L)
- •Patient unwilling to provide written informed consent
结局指标
主要结局
Uptake of CuATSM in carotid plaque
时间窗: Within 30 days of carotid endarterectomy
次要结局
- Relationship of CuATSM uptake to plaque histology(Within 30 days of carotid endarterectomy)
研究者
Matthew Waltham
Senior Lecturer
King's College London
研究点 (1)
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