SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)
研究概览
简要总结
The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of abdominal aortic aneurysm expansion.
详细描述
Ruptured abdominal aortic aneurysms (AAAs) have a 90% mortality rate but there are currently no accurate methods of establishing the risk of rupture for an individual patient with an asymptomatic AAA. In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early micro calcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. The study investigators therefore propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in AAA and predict AAA expansion. The study investigators will explore its value as part of an ongoing clinical trial assessing the identification of macrophage activity using magnetic resonance imaging - the MA3RS Study (ISRCTN76413758). Patients already enrolled in the MA3RS Study will be recruited for the SoFIA3 study. Control patients with a normal calibre aorta will be recruited from the National AAA Screening Programme.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients expected to undergo imminent AAA repair
- •Patients who refuse or are unable to give informed consent
- •Women of child-bearing potential without contraception
- •Patients who are unable to undergo PET-CT scan
- •Patients with collagen vascular disease
- •Intercurrent illness, malignancy or comorbidity with life expectancy <1 year
- •Renal dysfunction (eGFR <30ml/min/1.73m2)
- •Contraindication to PET-CT or CTA
- •Iodine allergy
结局指标
主要结局
Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)
时间窗: 0, 6, 12 months
The maximum AAA AP diameter on ultrasound will be obtained from time points below: 1. At (or close to) the time of the study visit 2. 6 months following the study visit 3. 12 months following the study visit The maximum AP diameter will also be recorded on CTA performed at the time of study visit.
次要结局
- Co-localisation of 18F-NaF with USPIO uptake on MRI scanning(At baseline)
