Molecular imaging of plaque vulnerability

Phase 1

• Conditions: Patients with carotid artery stenosis due to atherosclerosis, who are scheduled for carotid endarterectomy or are treated conservatively.; MedDRA version: 21.1 Level: PT Classification code 10066537 Term: Atherosclerosis prophylaxis System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-000456-17-NL
• Lead Sponsor: niversity Hospital Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Patients with symptomatic carotid artery stenosis, who are scheduled for carotid endarterectomy or conservative treatment.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

-Severe comorbidity, dementia, pregnancy, breast feeding;
-Serious neurological deficits (hemiparalysis, complete aphasia).
-Severe heart failure and severe pulmonary dysfunction dependent on oxygen supply;
-Patients with contra-indications for MRI

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether intraplaque inflammation can be measured using 18F-fluormethylcholine positron emission tomography- magnetic resonance imaging (PET-MRI).;<br> Secondary Objective: -To correlate the intraplaque 18F-fluormethylcholine uptake on PET-MRI with the cardiovascular risk profile of patients;<br> -To correlate the intraplaque 18-fluormethylcholine uptake on PET-MRI with MRI parameters of plaque vulnerability.<br> ;<br> Primary end point(s): -To correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque, as a measure of plaque inflammation and vulnerability on histology;<br> -To determine the sensitivity, specificity, negative predictive value of 18F-choline PET in diagnosis of vulnerable plaques.<br> ;Timepoint(s) of evaluation of this end point: Last visit last subject (LVLS).

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -The correlation between SUV, TBR of 18F-fluormethylcholine with patients' cardiovascular risk factors and medical history;<br> -The correlation between SUV, TBR of 18F-fluormethylcholine with MRI parameters of plaque vulnerability.<br> -The correlation between SUV, TBR of 18F-fluormethylcholine with established FDG PET imaging paramaters<br> -To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery.<br> -To correlate the intra-plaque 18F-choline uptake on PET with other histologic plaque parameters besides inflammation, such as the total area of intra-plaque lipid core, haemorrhage, fibrous tissue and calcifications;<br> ;Timepoint(s) of evaluation of this end point: LVLS