Clinical Trial: 18F-choline PET-CT and MRI of Carotid Plaques

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Plaque at Risk (ParisK): Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-CT and MRI in Patients With Carotid Artery Atherosclerosis

Brief Summary: Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a sensitive molecular tracer for PET-CT imaging that is taken up in activated cells and, as such, is able to identify active inflammatory sites.

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-CT in identifying ongoing inflammation within atherosclerotic plaques. We hypothesize that 18F-choline is efficient in detecting intraplaque inflammation.
Sponsor: Maastricht University Medical Center

Current Primary Outcome: To correlate the 18F-choline uptake in the atherosclerotic plaque with the degree of intraplaque inflammation, as assessed on histology. [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To correlate the intra-plaque 18F-choline uptake on PET with other histologic plaque parameters besides inflammation. [ Time Frame: 1 year ]
  • To correlate the intra-plaque 18F-choline uptake on PET with atherosclerotic plaque parameters assessed on CT, MRI, and ultrasound. [ Time Frame: 1 year ]
  • To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery. [ 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. [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: July 10, 2013
Date Started: July 2013
Date Completion: December 2015
Last Updated: April 9, 2015
Last Verified: April 2015