18F-Flutemetamol and Plaque Vulnerability
Atherosclerosis

About this trial
This is an interventional diagnostic trial for Atherosclerosis focused on measuring PET/MRI, Amyloid, Flutemetamol
Eligibility Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
All patients:
- Age18years and older (no maximum age)
- Informed consent by signed informed consent form regarding this study
Patients, who are scheduled for carotid endarterectomy:
o Inclusion criteria for carotid endarterectomy:
- Symptomatic stenosis (TIA or CVA) within last 14days and high grade stenosis (70-99%)
- In men, carotid artery stenosis between 50-69% is considered significant when related to clinical symptoms
Patients, who are not scheduled for carotid endarterectomy:
Patients who have experienced a TIA/CVA/amaurosis fugax (a 'TIA of the eye') within the last 14 days and abnormal findings on imaging of the carotids:
- Women with an ipsilateral carotid artery stenosis between 30-69% based on duplex ultrasonography, CTA, or MRA
- Men with an ipsilateral carotid artery stenosis between 30-49% based on duplex ultrasonography, CTA, or MRA
- Patients meeting inclusion criteria for carotid endarterectomy, but with contra- indications for CEA
Exclusion Criteria:
All patients:
- 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 or thrombogenic diathesis)
- Pregnant women and nursing mothers
Contra-indications for MRI (49):
- Ferromagnetic implants, such as pacemakers and other electronic implants
- Ferromagnetic (intracerebral) vascular clips
- Metallic cochlear implants
- Metallic splinters in eye(s) or other magnetic metallic foreign bodies elsewhere
- Claustrophobia
Relative contra-indications for MRI-contrast agents (50):
- GFR <30ml/min/1,73m2
- Previous allergic reaction to MRI contrast agent
Contra-indication 18F-Flutemetamol:
- Known allergic reaction to flutemetamol or polysorbate 80 or any of the excipients.
- Severe liver dysfunction.
Patients undergoing CEA:
- Comorbidity associated with high operative risk
- Occlusion of the internal carotid artery on the symptomatic side
- Near occlusion on the symptomatic side
- Complete infarction of the symptomatic anterior circulation/severe neurological deficit
Sites / Locations
- Maastricht University Medical Centre (MUMC+)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
18F-Flutemetamol PET/MRI dynamic
18F-Flutemetamol PET/MRI CEA
18F-Flutemetamol PET/MRI
All included patients will be patients with a recent stroke and a significant carotid plaque. The first 5 patients will undergo a slightly longer scan protocol to determine optimal scan time for the use of 18F-Flutemetamol in atherosclerosis imaging.
10 patients will be selected from patients that will undergo carotid endarterectomy (CEA) and will undergo the the optimized (shorter) scan protocol with 18F-Flutemetamol. The decision for this operation is made by the surgeon and neurologist and based on clinical standards and is thus independent of study participation.
The remaining 10 patients will undergo the optimized (shorter) scan protocol with 18F-Flutemetamol.