This trial is active, not recruiting.

Condition plaque, atherosclerotic
Treatment 18f-choline pet-ct imaging
Phase phase 3
Sponsor Maastricht University Medical Center
Collaborator Center for Translational Molecular Medicine
Start date July 2013
End date December 2015
Trial size 10 participants
Trial identifier NCT01899014, 2013-000456-17, NL43466.068.13


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Drug: 18F-choline, dosis 4 MBq/kg body-weight (maximum 360 MBq), administered intravenously as a single dose. Procedure: dynamic and static 18F-choline PET-CT imaging.
18f-choline pet-ct imaging 18F-fluormethylcholine
18F-choline PET-CT imaging

Primary Outcomes

To correlate the 18F-choline uptake in the atherosclerotic plaque with the degree of intraplaque inflammation, as assessed on histology.
time frame: 1 year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient is a female or male of ay race age >18 years at the time of the investigational product administration (no maximum age); - Informed consent by signing informed consent form regarding this study; - Patients known with carotid artery stenosis >50%, who are scheduled for carotid endarterectomy. Exclusion Criteria: - Dementia, pregnancy, nursing mothers; - Patients who do have a documented allergy for CT contrast media; - Patients with a renal clearance <45 ml/min/1.73m2 or <60 ml/min/1.73m2 in patients with diabetes mellitus; - Serious neurological deficits at symptomatic side (hemi paralysis, complete aphasia); - Severe heart failure NYHA III-IV and severe pulmonary dysfunction dependent on oxygen supply.

Additional Information

Official title Plaque at Risk (ParisK): Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-CT and MRI in Patients With Carotid Artery Atherosclerosis
Principal investigator S.A. Vöö, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.