PET/MRI and plaque vulnerability: Flutemetamol

PET/MRI and plaque vulnerability A feasibility study of 18F-Flutemetamol in atherosclerosis - PET/MRI and plaque vulnerability: Flutemetamol

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002911-16-NL

Enrollment

Registered

2016-11-03

Start date

2016-12-28

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis in the carotids and coronary arteries.

Interventions

Trade Name: Vizamyl Product Name: 18F-Flutemetamol Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 flow velocities with duplex ultrasonography. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.;Secondary Objective: To explore a possible relation between tracer uptake in the carotids and cognitive symptoms or radiological characteristics of (early) dementia.;Primary end point(s): Target-to-background-ratio in the symptomatic carotid artery plaque.;Timepoint(s) of evaluation of this end point: After 25 patients.	—

Measure

Time frame

Main Objective: To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.;Secondary Objective: To explore a possible relation between tracer uptake in the carotids and cognitive symptoms or radiological characteristics of (early) dementia.;Primary end point(s): Target-to-background-ratio in the symptomatic carotid artery plaque.;Timepoint(s) of evaluation of this end point: After 25 patients.

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Secondary

Measure	Time frame
Secondary end point(s): MRI and (when available) histologic measures of plaque vulnerability characteristics. Tracer uptake in the coronary arteries;Timepoint(s) of evaluation of this end point: After 25 patients.	—

Countries

Netherlands

Contacts

Public ContactNuclear Medicine dept.

Maastricht University Medical Center

00310433874746

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026