E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059696 |
E.1.2 | Term | Scan with contrast |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Following the UPSIO enhanced MR imaging of abdominal aortic aneurysm, patients will continue with their routine clinical surveillance ultrasound scan for 2 years. The last ultrasound scan will be the end point of the study for the patients. If however, patients go to surgery for their aortic aneurysm before that, that will be their point of exit from the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |