Clinical Trial: 18F-choline and 18F-FDG PET-MR of Symptomatic Carotid Plaques

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Symptomatic Carotid Artery Plaques With Positron Emission Tomography-magnetic Resonance Imaging (ESCAPPE)

Brief Summary: Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such, is able to identify active inflammatory sites. The investigators hypothesize that 18F-choline is also highly taken up in vulnerable plaques in comparison to the stable ones.

Detailed Summary:

Accumulation and subsequent activation of inflammatory cells in the atherosclerotic plaques play an essential role in transforming a stable plaque into a vulnerable plaque at risk to rupture. On this basis, the study aims to evaluate the diagnostic performance of 18F-choline PET in identifying ongoing inflammation within atherosclerotic plaques. The investigators hypothesize that 18F-choline PET is efficient in detecting intraplaque inflammation and identify vulnerable plaques that are prone to rupture in comparison to the stable ones.

It is likely that by correlating the inflammatory status of an atherosclerotic plaque (on 18F-choline PET) with the presence of other vulnerable plaque features (on MR imaging) would be of high clinical relevance for clinical diagnosis of vulnerable plaques.


Sponsor: Maastricht University Medical Center

Current Primary Outcome: 18F-choline uptake, as marker of plaque inflammation [ Time Frame: 1 year ]

To correlate the 18F-choline uptake in the atherosclerotic plaque with the degree of intraplaque inflammation, as assessed by histology.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 18F-choline uptake and other markers of vulnerable plaques [ Time Frame: 1 year ]
    To correlate the intra-plaque 18F-choline uptake on PET with atherosclerotic plaque parameters assessed on MRI.
  • 18F-choline uptake vs cardiovascular risk factors [ Time Frame: 1 year ]
    To evaluate a possible association between the degree of 18F-choline uptake on PET with patients' cardiovascular risk profile and medical history.


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: December 22, 2015
Date Started: December 2015
Date Completion: December 2018
Last Updated: May 17, 2017
Last Verified: May 2017