EUCTR2009-009421-29-GB
Active, not recruiting
Phase 1
on - invasive assessment of inflammatory burden in small abdominal aortic aneurysms: A USPIO - enhanced Magnetic Resonance Imaging (MRI) study - USPIO enhanced MRI of AAAs
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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