The use of magnetic resonance imaging and a novel contrast agent to predict rupture or need for surgical repair in patients under surveillance with abdominal aortic aneurysms.

Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide in Patients Under Surveillance for Abdominal Aortic Aneurysms to Predict Rupture or Surgical Repair: the MA3RS Trial - MAR3S Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002448-25-GB

Enrollment

350

Registered

2012-08-28

Start date

2012-10-02

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Rienso Product Name: Ferumoxytol Pharmaceutical Form: Solution for injection INN or Proposed INN: iron Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Abdominal aortic aneurysms measuring =40mm in anteroposterior diameter on ultrasound scanning. 2. Age =40 years. Patients with abdominal aortic aneurysms less than 40 years may have a connective tissue disorder and a different aetiology to their disease. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 234

Exclusion criteria

Exclusion criteria: 1. Patients expected to undergo imminent elective or emergency surgical or endovascular repair. 2. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging 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 - allergy to MRI contrast enhancement agent 3. Patients refusing or unable to give informed consent 4. Woman with child-bearing potential will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant). 5. Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy (life expectancy < 2 years). 6. Renal dysfunction (eGFR =30 mL/min/1.73m2). 7. Polycythemia. 8. Contraindication to ferumoxytol (evidence of iron overload, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency).

Design outcomes

Primary

Measure	Time frame
Main Objective: An abdominal aortic aneurysm is a swelling of the main blood vessel that supplies the organs in the abdomen and the legs. It most commonly occurs just below the kidneys (approximately at the level of the belly button). It is not yet clear why some people develop aneurysms but they are more common in smokers and in men. Abdominal aortic aneurysms are dangerous because they can rupture and if this happens up to 90% of people affected will die. Of those who make it to hospital, they have a less than 50% chance of surviving. At present, we use size, measured by an ultrasound scan, to best predict which abdominal aortic aneurysms are most likely to rupture. The problem with this is that sometimes small abdominal aortic aneurysms rupture and large abdominal aortic aneurysms go on to grow to 10cm without rupturing. This suggests that size is not the only factor to cause abdominal aortic aneurysms to grow and rupture. The principal objective of this study is to use magnetic resonance;Secondary Objective: This study will look at patients under surveillance for abdominal aortic aneurysms. We will evaluate the uptake of the new imaging agent into the wall of the aneurysm, using an magnetic resonance imaging scan to see if this: 1. correlates with the rate of expansion of the abdominal aortic aneurysm. 2. occurs more commonly in patients who progress to surgery or whose aneurysm subsequently ruptures 3. relates to the amount of stress the abdominal aortic aneurysm is under from the force of blood pushing against it and whether this can predict which abdominal aortic aneurysm will grow at a faster or slower rate. 4. can provide a predictor of risk in addition to standard risk markers, such as smoking and high blood pressure. 5. occurs in a reproducible manner. 6. relates to the degree of new vessel formation and inflammation and how this contributes to abdominal aortic aneurysm growth rate.;Primary end point(s): To determine whether mural uptake of	—

Measure

Time frame

Main Objective: An abdominal aortic aneurysm is a swelling of the main blood vessel that supplies the organs in the abdomen and the legs. It most commonly occurs just below the kidneys (approximately at the level of the belly button). It is not yet clear why some people develop aneurysms but they are more common in smokers and in men. Abdominal aortic aneurysms are dangerous because they can rupture and if this happens up to 90% of people affected will die. Of those who make it to hospital, they have a less than 50% chance of surviving. At present, we use size, measured by an ultrasound scan, to best predict which abdominal aortic aneurysms are most likely to rupture. The problem with this is that sometimes small abdominal aortic aneurysms rupture and large abdominal aortic aneurysms go on to grow to 10cm without rupturing. This suggests that size is not the only factor to cause abdominal aortic aneurysms to grow and rupture. The principal objective of this study is to use magnetic resonance;Secondary Objective: This study will look at patients under surveillance for abdominal aortic aneurysms. We will evaluate the uptake of the new imaging agent into the wall of the aneurysm, using an magnetic resonance imaging scan to see if this: 1. correlates with the rate of expansion of the abdominal aortic aneurysm. 2. occurs more commonly in patients who progress to surgery or whose aneurysm subsequently ruptures 3. relates to the amount of stress the abdominal aortic aneurysm is under from the force of blood pushing against it and whether this can predict which abdominal aortic aneurysm will grow at a faster or slower rate. 4. can provide a predictor of risk in addition to standard risk markers, such as smoking and high blood pressure. 5. occurs in a reproducible manner. 6. relates to the degree of new vessel formation and inflammation and how this contributes to abdominal aortic aneurysm growth rate.;Primary end point(s): To determine whether mural uptake of

—

Secondary

Measure	Time frame
Secondary end point(s): 1. The correlation between rate of aneurysm expansion and mural uptake of USPIO on MRI scanning. 2. To identify whether mural uptake of USPIO in MRI scanning occurs more commonly in patients who progress to surgery or whose aneurysm subsequently ruptures 3. The correlation between areas of biomechanical stress and mural uptake of USPIO on MRI scanning. 4. To identify whether mural uptake of USPIO in MRI scanning occurs in a reproducible manner.;Timepoint(s) of evaluation of this end point: Points 1-3: 24 months follow up. Point 4: evaluation at 1 month and 1 year.	—

Measure

Time frame

Secondary end point(s): 1. The correlation between rate of aneurysm expansion and mural uptake of USPIO on MRI scanning. 2. To identify whether mural uptake of USPIO in MRI scanning occurs more commonly in patients who progress to surgery or whose aneurysm subsequently ruptures 3. The correlation between areas of biomechanical stress and mural uptake of USPIO on MRI scanning. 4. To identify whether mural uptake of USPIO in MRI scanning occurs in a reproducible manner.;Timepoint(s) of evaluation of this end point: Points 1-3: 24 months follow up. Point 4: evaluation at 1 month and 1 year.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026