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: L
Conditions
Interventions
Product Name: Sinerem
Product Code: G534.70 (Sinerem)
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients aged 18-90 years with small infra-renal AAAs (> 4.0 cm to 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 hotspots, we hope to develop a novel method of assessing which aneurysms are at risk of rupture or sudden expansion. ;Secondary Objective: To complement our ongoing finite element analysis (FEA) studies. By performing stress analysis, we want to investigate the relationship between high stress, high inflammation and rapid aneurysm expansion and vice-versa. We have recently shown co-localisation of maximum stress points with USPIO uptake in carotid atheroma and would like to perform similar simulations on AAA. Our group has already successfully used the computational modelling of aneurysm to assess the impact of calcification and intraluminal thrombus on aneurysm stress.;Primary end point(s): 50 patients will be identified and recruited: There will be two cohort groups with 25 patients having a stable AAA (0cm to < 0.4 cm expansion in the prior twelve month period) and 25patients with a rapidly expanding AAA (= 0.4 cm expansion in a twelve month period). Once these have been identified they will be recruited for USPIO - enhanced MR imaging of their AAA following their clinical ultrasound scan. Following this they will continue their follow-up ultrasound scans to measure the aneurysm expansion which will be correlated with the patient’s degree of inflammation as defined by their initial USPIO-enhanced MR scan. | — |
Countries
United Kingdom
Outcome results
None listed