New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms

NCT05976711 | Completed

• 1 other identifier: 2008987
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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 imprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurrence 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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Keywords

Abdominal Aortic Aneurysm; Magnetic Resonance Imaging; 4D flow MRI; DCE MRI

Outcome Measures

Primary Outcomes (3)

• Surveillance: correlation between growth rate and MRI derived parameters

  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.

  1 year

• EVAR planning: correlation between morphological parameters measured based on MRA and CTA

  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.

  half year

• EVAR follow up: difference in MRI parameters between patients with endoleaks and without

  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.

  1 year

Study Arms (3)

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)

EVAR planning

10 patients will undergo magnetic resonance angiography next to the standard of CT angiography (CTA). It is investigated whether EVAR planning is feasible based on MRA and if or how measurements between MRA and CTA differ.

Device: Magnetic resonance imaging (with PROUD software)

EVAR follow-up

30 AAA patients who underwent EVAR will be included in three groups: 10 patients with ten complication free years after EVAR or sac regression, 10 patients with endoleak type I and 10 patients with endoleak type II. It is investigated whether MRI can provide extra information for the detection of endoleaks after EVAR.

Device: Magnetic resonance imaging (with PROUD software)

Interventions

Magnetic resonance imaging (with PROUD software) DEVICE

Philips Ingenia 3.0T MR system with in-house developed PROUD software

Also known as: 4D flow MRI, DCE-MRI

EVAR follow-up; EVAR planning; Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an AAA from the Amsterdam UMC

You may qualify if:

• diagnosed with AAA
• provision of written informed consent
• maximum AAA diameter between 3-5 cm
• planned for elective EVAR
• ten complication free years after EVAR or sac regression after EVAR; or
• type I endoleak after EVAR; or
• type II endoleak after EVAR;

You may not qualify if:

• Supra- or pararenal AAA
• Inflammatory, infectious or mycotic AAA
• Vasculitis and connective tissue disease
• Patients that underwent open surgical repair for their AAA
• Patients with ruptured AAAs
• Patients that previously presented with allergic reactions to intravenous contrast agents
• previous AAA repair
• severely reduced renal function
• previous allergic reactions to intravenous contrast agents
• previous AAA repair
• severely reduced renal function
• previous allergic reactions to intravenous contrast agents

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Brightfish: collaborator
• Nano4Imaging GmbH: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Magnetic Resonance Imaging; Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 4, 2023
• Study Start: May 4, 2023
• Primary Completion: March 13, 2025
• Study Completion: June 12, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)