Clinical trial NCT02640313: Molecular Imaging of Plaque Vulnerability
Official title: Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-MRI in Carotid Artery Atherosclerosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque, Atherosclerotic
Keywords: 18F-fluormethylcholine
[F18] choline
[F18] fluormethylcholine
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 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.

Eligibility criteria: Inclusion Criteria:

* Patients known with symptomatic carotid artery stenosis (≥2 mm carotid plaque on duplex ultrasound), who are scheduled in the clinical setting to undergo a carotid endarterectomy or who are referred to conservative therapy;
* Age 18 years and older (no maximum age);
* Informed consent by signing informed consent form regarding this study.

Exclusion Criteria:

* Dementia, pregnancy, nursing mothers;
* Serious neurological deficits at symptomatic side (hemi paralysis, complete aphasia);
* Severe heart failure NYHA III-IV and severe pulmonary dysfunction dependent on oxygen supply;
* Patients with contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic splinters in the eyes, vascular clips, claustrophobia, etc.).

Primary outcomes:
measure: 18F-choline uptake, as marker of plaque inflammation
timeFrame: 1 year
measure: correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque
timeFrame: 1 year
measure: sensitivity, specificity, negative predictive value of 18F-choline PET
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of F18-Choline uptake vs other histologic plaque parameters.
timeFrame: 1 year
measure: Correlation of F18-Choline uptake vs PET and MRI parameters of atherosclerotic plaque
timeFrame: 1 year
measure: Correlation of F18-choline plaque uptake vs 18F-FDG uptake
timeFrame: 1 year
measure: Symptomatic vs asymptomatic F18-Choline uptake
timeFrame: 1 year
measure: Correlation of F18choline plaque uptake vs cardiovascular risk profile
timeFrame: 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: M. Eline Kooi, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Jochem van der Pol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bucerius J, Schmaljohann J, Bohm I, Palmedo H, Guhlke S, Tiemann K, Schild HH, Biersack HJ, Manka C. Feasibility of 18F-fluoromethylcholine PET/CT for imaging of vessel wall alterations in humans--first results. Eur J Nucl Med Mol Imaging. 2008 Apr;35(4):815-20. doi: 10.1007/s00259-007-0685-x. Epub 2008 Jan 6.
citation: Forster S, Rominger A, Saam T, Wolpers S, Nikolaou K, Cumming P, Reiser MF, Bartenstein P, Hacker M. 18F-fluoroethylcholine uptake in arterial vessel walls and cardiovascular risk factors: correlation in a PET-CT study. Nuklearmedizin. 2010;49(4):148-53. doi: 10.3413/nukmed-0299. Epub 2010 Jun 8.
citation: Kato K, Schober O, Ikeda M, Schafers M, Ishigaki T, Kies P, Naganawa S, Stegger L. Evaluation and comparison of 11C-choline uptake and calcification in aortic and common carotid arterial walls with combined PET/CT. Eur J Nucl Med Mol Imaging. 2009 Oct;36(10):1622-8. doi: 10.1007/s00259-009-1152-7. Epub 2009 May 9.
citation: Voo S, Kwee RM, Sluimer JC, Schreuder FH, Wierts R, Bauwens M, Heeneman S, Cleutjens JP, van Oostenbrugge RJ, Daemen JW, Daemen MJ, Mottaghy FM, Kooi ME. Imaging Intraplaque Inflammation in Carotid Atherosclerosis With 18F-Fluorocholine Positron Emission Tomography-Computed Tomography: Prospective Study on Vulnerable Atheroma With Immunohistochemical Validation. Circ Cardiovasc Imaging. 2016 May;9(5):e004467. doi: 10.1161/CIRCIMAGING.115.004467.