MARVY: New MRI Techniques for Diagnosis and Treatment of Abdominal Aortic Aneurysms
Study Details
Study Description
Brief Summary
An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. To prevent rupture elective surgery can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is inserted into the AAA to prevent it from further growth and rupture.
Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to determine upon timing of elective repair but is unprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurence remain unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US) utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced MRI techniques are used to find out if standard imaging techniques could be replaced by MRI in three phases of the AAA management (surveillance, surgery planning and post-operative follow-up). The two most important MRI techniques that will be used are 4D flow MRI and dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow within the AAA and perfusion of the aortic wall.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surveillance 20 AAA patients will undergo two MRI scans with a half year interval to assess a possible correlation between MRI derived biomarkers and the clinical standard to assess aneurysm progression (maximum AAA diameter). |
Device: Magnetic resonance imaging (with PROUD software)
Philips Ingenia 3.0T MR system with in-house developed PROUD software
Other Names:
|
| EVAR planning 10 patients will undergo magnetic resonance angiography next the the standard of CT angiography (CTA). We want to find out whether we can plan an EVAR also based on MRA or that there would be great differences. |
Device: Magnetic resonance imaging (with PROUD software)
Philips Ingenia 3.0T MR system with in-house developed PROUD software
Other Names:
|
| EVAR follow-up 30 AAA patients who underwent EVAR will be included in three groups: 10 patients with no complications ten year after EVAR or sac regression, 10 patients with endoleak type I and 10 patients with endoleak type II. We want to know if MRI can give extra information for the detection of endoleaks after EVAR. |
Device: Magnetic resonance imaging (with PROUD software)
Philips Ingenia 3.0T MR system with in-house developed PROUD software
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Surveillance: correlation between growth rate and MRI derived parameters [1 year]
The main study parameter for phase B1 (surveillance) is the correlation between growth rate of the AAA (determinant for the standard of care) and measured MRI parameters acquired with 4D flow MRI and DCE-MRI.
- EVAR planning: correlation between morphological parameters measured based on MRA and CTA [half year]
The main study parameter for phase B2 (EVAR planning) is the difference between anatomical measurements (lengths and diameters) based on both CTA and MRA. Several quantitative anatomical measurements will be utilised to assess the feasibility of MRA for planning of EVARs.
- EVAR follow up: difference in MRI parameters between patients with endoleaks and without [1 year]
The main study parameter for phase B3 (EVAR follow-up) is the difference in MRI parameters measured post-operatively in patients with and without EVAR related complications.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
diagnosed with AAA
-
provision of written informed consent
Inclusion Criteria for surveillance part:
-
maximum AAA diameter between 3-5 cm
-
not scheduled for aneurysm repair at the time of inclusion
Inclusion Criteria for planning part:
- planned for elective EVAR
Inclusion Criteria for follow-up part:
-
ten complication free years after EVAR or sac regression after EVAR; or
-
type I endoleak after EVAR; or
-
type II endoleak after EVAR;
Exclusion Criteria:
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Supra- or pararenal AAA
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Inflammatory, infectious or mycotic AAA
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Vasculitis and connective tissue disease
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Patients that underwent open surgical repair for their AAA
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Patients with ruptured AAAs
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Patients that previously presented with allergic reactions to intravenous contrast agents
Exclusion Criteria for surveillance part:
-
previous AAA repair
-
severly reduced renal function
-
previous allergic reactions to intravenous contrast agents
Exclusion Criteria for planning part:
- previous AAA repair
Exclusion Criteria for follow-up part:
-
severly reduced renal function
-
previous allergic reactions to intravenous contrast agents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Amsterdam UMC | Amsterdam | Noord-Holland | Netherlands | 1105 AZ |
Sponsors and Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Brightfish
- Nano4Imaging GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2008987