PET/MRI and plaque vulnerability: Flutemetamol

Phase 1

• Conditions: Atherosclerosis in the carotids and coronary arteries.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002911-16-NL
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-03
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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