To investigate the diagnostic accuracy of subtractionless first-pass single contrast medium dose (0.1 mmol/kg) peripheral magnetic resonance angiography (MRA) using two-point mDixon fat suppression in comparison to the established standard of…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the diagnostic accuracy (sensitivity, specificity, NPV and PPV)
for the detection and the severity (%) of peripheral vascular tree stenosis
with subtractionless first-pass single contrast medium dose peripheral MR
angiography using two-point mDixon fat suppression compared to IA-DSA in
patients with peripheral arterial disease referred for percutaneous
intervention.
Secondary outcome
1. To compare the diagnostic accuracy of subtractionless first-pass single
mDixon MRA with conventional subtraction MRA compared to the reference standard
DSA in patients with peripheral arterial disease referred for percutaneous
intervention in participating centers performing subtraction MRA in their
clinical routine workup.
2. Does mDixon MRA lead to similar treatment decisions as IA-DSA determined by
an expert consensus panel consisting of experienced cardiovascular radiologists
and vascular surgeons
3. To compare the diagnostic accuracy of mDixon MRA on a station by station
level (i.e. at the aorto-iliac, upper leg and lower leg levels).
Background summary
Recently, a novel peripheral MR angiography method has been described that
utilizes the principles of Dixon water/fat imaging to perform subtractionless
imaging of the peripheral vascular tree. The diagnostic accuracy of this
technique in relation to an established standard of reference has not been
investigated.
Study objective
To investigate the diagnostic accuracy of subtractionless first-pass single
contrast medium dose (0.1 mmol/kg) peripheral magnetic resonance angiography
(MRA) using two-point mDixon fat suppression in comparison to the established
standard of reference, intra-arterial digital subtraction angiography.
Study design
multi-center prospective diagnostic cross-sectional study
Study burden and risks
Patients undergo the standard imaging that is used in the participating
centers. To obtain the data to answer our research question patients will
undergo an additional MR angiography examination. No harm minimal additional
burden is expected based on our study design. Therefore, risks are negligible.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Suspected presence of peripheral arterial disease based on duplex ultrasonography,
magnetic resonance angiography or CT angiography requiring percutaneous intervention
- willing and able to give informed consent
Exclusion criteria
- Presence of metal implants incompatible with safe MR imaging as determined from the
recent copy of the *MR safety manual* by Shellock et al.
- claustrophobia
- presence of metal fragments in the orbit or eye
- severe renal impairment (GFR<30 mL/min/m2)
- contrast-allergy for gadolinium chelates
Design
Recruitment
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 | NL47827.041.14 |