on - invasive assessment of inflammatory burden in small abdominal aortic aneurysms: A USPIO - enhanced Magnetic Resonance Imaging (MRI) study - USPIO enhanced MRI of AAAs

Phase 1

• Conditions: The thrust of this pilot study is to investigate the utility of USPIO - enhanced MR to image abdominal aortic aneurysms with the aim of highlighting focal areas of inflammation and macrophage infiltration and correlating them with the degree of expansion. By targeting these inflammatory hot spots, we hope to develop a novel method of assessing which aneurysms are at risk of rupture or sudden expansion and improve risk stratification.; MedDRA version: 9.1 Level: LLT Classification code 10059696 Term: Scan with contrast

• Registration Number: EUCTR2009-009421-29-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-09
• Study Completion: 2012-03-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. All patients aged 18-90 years with small infra-renal AAAs (> 4.0 cm to < 5.5 cm), which are either newly detected or under regular surveillance and which are not being considered for surgery or endovascular treatment.

2.Female subjects must be of non-childbearing potential (post-menopausal females who have been amenorrheic >1 year, or pre-menopausal females with a documented hysterectomy or bilateral oophorectomy.

3. Signed written informed consent prior to beginning study related procedures (subject must understand the aims, investigational procedures and possible consequences of the study).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of atopy, asthma, allergic reaction to contrast materials.
2. Known and documented history of renal impairment
3. Known and documented history of haemochromatosis
4. Contraindication to MRI imaging including but not limited to:
a)Intracranial aneurysm clips (except Sugita) with an appropriate operative conformation
b)History of intra- orbital metal fragments that have not been removed by an MD
c)Pacemakers and non-MR compatible heart valves
d)Inner ear implants
e)History of claustrophobia in MR
5. Inability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified