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临床试验/NCT01749280
NCT01749280终止不适用

Efficacy of Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide to Predict Clinical Outcome in Patients Under Surveillance for Abdominal Aortic Aneurysms

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
To determine if uptake ultrasmall superparamagnetic particles of iron oxide as determined by percentage R2* change between pre-and post-constant scan will predict abdominal aortic aneurysm growth and rupture in patients with abdominal aortic aneurysms.

研究概览

简要总结

The aorta is the main blood vessel that comes out of the heart and distributes blood to the whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it passes through the abdomen. These 'abdominal aortic aneurysms' often occur without symptoms and can burst or rupture without warning. This usually leads to death and represents the thirteenth commonest cause of death in the United Kingdom. In this study, we are looking at a new technique that can look at the aortic aneurysm using magnetic resonance imaging; a technique that does not require x-rays or radiation. We have recently shown that, using magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh that will invite all patients who are under surveillance because of an aneurysm. We will image these patients using this novel technique and see if we can identify which patients burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die. This will be important to establish as it will potentially lead to a new way of managing people that could ultimately save lives. This is particularly timely as national screening and surveillance programmes are currently being launched.

详细描述

HYPOTHESIS We hypothesise that uptake of ultrasmall supraparamagnetic particles of iron oxide into the aortic wall will predict abdominal aortic aneurysm growth and clinical outcomes.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an abdominal aortic aneurysm >40 mm

排除标准

  • Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, or clinical laboratory examination that is deemed by the principal investigator and/or designee to make the subject ineligible for inclusion.
  • Subjects with planned AAA surgery.
  • Renal impairment with eGFR of <30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.
  • Women of child-bearing potential without contraception,
  • Collagen-vascular disease.
  • Inability to undergo magnetic resonance or computed tomography scanning,
  • Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to:
  • Intracranial aneurysm clips (except Sugita) or other metallic objects,
  • History of intra- orbital metal fragments that have not been removed,
  • Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves,
  • Inner ear implants,
  • History of claustrophobia in MR.

结局指标

主要结局

To determine if uptake ultrasmall superparamagnetic particles of iron oxide as determined by percentage R2* change between pre-and post-constant scan will predict abdominal aortic aneurysm growth and rupture in patients with abdominal aortic aneurysms.

时间窗: 2 yrs

The change of R2\* signal which is determined by the USPIO uptake within the issues will be used to assess the change between pre-and post contrast MRI scans. The investigators will assess if macrophage activity as determined by USPIO change predicts AAA growth and rupture

Does USPIO uptake as determined by percentage change between pre-and post contrast scan co-relates with FDG PET standardised uptake values or tissue to background ratios.

时间窗: 2 yrs

As per ethical approval, we have recruited patients under AAA PET study to look at USPIO correlation with 18F-FDG PET. The cellular inflammation can be assessed by USPIO uptake, whilst the metabolic activity can be determined by 18F-FDG PET. In this study, the investigators will determine if there is a correlation between the these two imaging modalties by comparing the R2\* change using MRI and standardised uptake values using FDG PET.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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