An Investigation of the Role of 18F-Sodium Fluoride and 18F-Flurodeoxyglucose PET CT and USPIO Enhanced MRI in Imaging Carotid Artery Inflammation and Mineralization.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The Standardized Uptake Value (SUV) for 18F-Fluoride of the ipsilateral carotid artery
研究概览
简要总结
Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with hardening of the neck arteries due to undergo surgery to remove the hardened areas. The investigators will then be able to compare the hot spots found on these scans with what the investigators can see in the removed specimens under the microscope in the laboratory. This will give investigators insight into the value of PET CT and MRI as tools for assessing atherosclerosis. It will also provide the investigators with new information relating to the underlying processes that give rise to atherosclerosis and will pave the way for the future development of new treatments.
详细描述
Hardening of the arteries (atherosclerosis) is a very common health problem that can lead to fatal or disabling heart attacks and strokes. On many levels, it remains an incompletely understood illness.
Until relatively recently, the only way of assessing the severity of, or risk posed by, atherosclerosis was to measure the degree to which it narrowed a particular blood vessel. This method only tells part of the story; he investigators now know that frequently the 'culprit area' of atherosclerosis that causes the heart attack or stroke does not necessarily result in narrowing of the blood vessel - i.e. if the investigators only measure narrowness the investigators will miss lots of 'bad' atherosclerosis. As such, there is a pressing need to identify more sophisticated techniques of assessing the disease in order that people who are at higher risk of heart attack or stroke can be identified early and offered appropriate preventative treatment.
Techniques that provide this extra information could also significantly shorten the time it takes to get new treatments and drugs to market by providing a faster and more cost-effective way of assessing these treatments early in their development. Furthermore, in exploring new techniques that reflect more accurately what is going on within atherosclerosis in the body, deeper insight into the condition will be gained. This will in turn lead to the development of new treatments.
PET/CT scans and USPIO (a kind of tracer) enhanced MRI scans are two such techniques that demonstrate particular promise. These scanning methods not only provide more information about the composition and architecture of the atherosclerosis but can provide data about the processes (at the chemical and cellular level) that underlie the disease.
Inflammation and calcification (deposits of calcium) are two biological processes that are known to be very important in the genesis of atherosclerosis. PET/CT and USPIO enhanced MRI can detect these processes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with carotid stenosis due to undergo carotid endarterectomy.
排除标准
- •Patients with new stroke and a modified Rankin score >3
- •Chronic Kidney Disease with eGFR of <30 mL/min/1.73m2
- •Pregnant women
- •Poorly controlled diabetes mellitus (HbA1c > 8.5%) or diabetes mellitus requiring insulin
- •Prior ipsilateral carotid intervention
- •Prior neck irradiation
- •Inability to tolerate the supine position
- •Participation in the study would result in delay to surgery
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Specific contraindications to MRI (e.g. pacemaker)
- •History of allergic reaction attributed to ferumoxytol or similar
- •Known or suspected iron overload (genetic haemochromatosis or history of multiple transfusions)
- •History of allergic reaction attributed to 18F-FDG or 18F-NaF or similar
- •History of allergic reaction to iodine or iodine-based contrast media
结局指标
主要结局
The Standardized Uptake Value (SUV) for 18F-Fluoride of the ipsilateral carotid artery
时间窗: 1-2 days after PET/CT scan
The mean and maximum SUV (using 18F-NaF) of the ipsilateral carotid artery will be calculated and compared to its contra lateral partner. The SUV is a validated quantitative assessment of PET radiotracer uptake.
次要结局
- The SUV of 18F-Flurodeoxyglucose on PET/CT of the ipsilateral carotid artery(1-2 days after PET/CT scan)
- A correlation between ipsilateral carotid SUV of 18F-Fluoride and the gene expression characteristics of excised plaque.(Approximately 1 month after the PET/CT scan)
- A correlation between the ipsilateral carotid SUV of 18F-Fluoride and tissue markers of apoptosis and calcification.(Approximately 1 month after the PET/CT scan)
- A correlation between the ipsilateral carotid USPIO uptake and tissue markers of inflammation and apoptosis.(1 month after MRI scan)
- The presence or absence of USPIO (ultra-small superparamagnetic particles of iron oxide) uptake on MRI (magnetic resonance image) within the ipsilateral carotid artery compared to its contralateral partner.(1-2 days after MRI scan)
- A correlation between the ipsilateral carotid SUV of 18F-Flurodeoxyglucose and tissue markers of inflammation and apoptosis.(Approximately 1 month after PET/CT scan)
- A correlation between the ipsilateral carotid USPIO uptake and gene expression characteristics of excised atheroma.(1 month after the MRI scan)
- The ipsilateral carotid radioactivity, arterial blood radioactivity and whole blood fluoride concentration measured over time(During the 18F PET/CT scan)