The proposed pilot study will examine whether radiation-based CTA could be replaced with MRI in three phases of AAA management.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase 1: correlation between aneurysm growth (standard of care determinant for
risk of AAA progression and rupture) and measured MRI parameters. Phase 2:
difference between anatomical measurements (lengths and diameters) based on
both CTA and MRA. Phase 3: difference in MRI parameters measured
post-operatively in patients with and without EVAR related complications
Secondary outcome
-
Background summary
Standard AAA management has several drawbacks. To start: maximum AAA diameter
remains the central determinant in asymptomatic AAA management although it is
not always reliable in identifying patients at risk of rupture. Secondly, EVAR
outcome and occurrence of complications remain unpredictable due to poor
prediction ability of CTA and 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 (CTA, US, DSA) by magnetic resonance imaging (MRI).
Study objective
The proposed pilot study will examine whether radiation-based CTA could be
replaced with MRI in three phases of AAA management.
Study design
The proposed study is divided into two parts: part A and part B. Part A is a
pilot study to optimise the DCE MRI sequence before we will use it in part B.
Part B is an observational pilot study with participant inclusion in three
phases of the AAA management.
Study burden and risks
All risk associated with this study are related to the use of contrast agent.
Dotarem is registered for use with MRI. Its complications are rare.
Participation in this study may cause some discomfort to the patient due to the
MRI scan time of approximately 45 minutes. The total MRI visit including all
preparations will take approximately 2 hours.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
Provision of written informed consent
For the patients --> Diagnosed with an abdominal aortic aneurysm
Exclusion criteria
Contra-indications for MRI:
Pregnant and/or breastfeeding women
Patients -->
Supra- or pararenal AAA,
Inflammatory, infectious or mycotic AAA
Ruptured AAA
Patients that underwent open surgical repair
Patients that are hypersensitive to contrast agent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80822.029.22 |