To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tracer uptake in the carotid artery will be correlated to vulnerable plaque
characteristics on MRI. In the 5-10 CEA patients, tracer uptake and MR imaging
of different plaque characteristics will be validated with plaque histology of
the surgically removed specimen.
Secondary outcome
Tracer uptake in the brain.
Tracer uptake in the coronary arteries.
Radiological characteristics of (early) dementia, as assessed with brain MRI.
Medication use.
Cognitive symptoms based on subjective complaints prior to hospitalization.
Background summary
18F-flutemetamol is a PET tracer with high affinity for amyloid beta (Abeta).
This has been extensively studied in Alzheimer disease (AD) patients. However,
Abeta seems not only to be involved in AD pathology, but also has a role in
atherosclerosis, which might explain the remarkable similarities in risk
factors between these two pathologies. In vitro studies suggest that a major
part of this association is based on the ability of amyloid to lead to
macrophage activation and hence inflammation. These data lead to the hypothesis
that Abeta is associated with plaque vulnerability
Study objective
To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.
Study design
A cross-sectional validation study.
Study burden and risks
For optimal MR imaging patients will be injected with a Gadolinium based
contrast agent, which is a common procedure and associated with very low risk
of complications. The PET tracer 18F-flutemetamol has been studied extensively
and is currently used in patients with AD. Adverse events were not frequent and
mainly mild. The radioactivity dose will be minimized.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Age 18 years and older (no maximum age)
Informed consent by signed informed consent form regarding this study
Either: Patients, who are scheduled for carotid endarterectomy (CEA)
Or: Patients who are not scheduled to undergo a CEA, but have experienced a
TIA/CVA/amaurosis fugax within the last 14 days and at least a 30% stenosis of
the symptomatic carotid artery as based on imaging.
Exclusion criteria
Severe cognitive impairment, neurological deficit or comorbidity causing the
study to be too high a burden for the patient or disrupting patient*s
co-operation with scan procedures.
Evident other causality for stroke (cardiac embolus, small vessel disease,
carotid dissection or thrombogenic diathesis).
Pregnant women and nursing mothers.
Contra-indications for MRI.
*Relative contra-indications for MRI-contrast agent: GFR
<30ml/min/1,73m2/Previous allergic reaction to MRI contrast agent.
Contra-indication Flutemetamol: Hypersensitivity to the active substance or to
any of the excipients, severe liver dysfunction
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 |
|---|---|
| EudraCT | EUCTR2016-002911-16-NL |
| CCMO | NL58543.068.16 |