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

Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

Sponsors

Lead sponsor: University of Edinburgh

Collaborator: University of Cambridge

Source University of Edinburgh
Brief Summary

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.

Detailed Description

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.

Overall Status Terminated
Start Date March 2011
Completion Date August 2012
Primary Completion Date August 2012
Study Type Observational
Primary Outcome
Measure Time Frame
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. 2 yrs
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. 2 yrs
Enrollment 16
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

Patients with an abdominal aortic aneurysm >40 mm

Exclusion Criteria:

1. 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.

2. Subjects with planned AAA surgery.

3. Renal impairment with eGFR of <30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.

4. Women of child-bearing potential without contraception,

5. Collagen-vascular disease.

6. Inability to undergo magnetic resonance or computed tomography scanning,

7. 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.

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David Newby, MD PhD Principal Investigator University of Edinburgh
Location
facility Clinical Research Imaging Centre/ NHS LOTHIAN
Location Countries

United Kingdom

Verification Date

December 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Abdominal Aortic Aneurysms

Description: Patients will be recruited from the outpatient AAA surveillance population at the vascular unit in the Royal Infirmary of Edinburgh.Potential participation in the study will be completely asymptomatic from their AAA.

Study Design Info

Time perspective: Prospective

Source: ClinicalTrials.gov