Molecular Imaging of Plaque Vulnerability

Plaque, Atherosclerotic Clinical Trial

— PARISK  

Official title:

Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-MRI in Carotid Artery Atherosclerosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02640313
• Other study ID #: NL43466.068.13/ABR43466
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: Jochem van der Pol, MD
• Phone: +31 43 38 74746
• Email: jochem.vander.pol[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01899014

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Plaque, Atherosclerotic

Intervention

Drug:
• 18F-choline PET-MR imaging
Dynamic and static 18F-choline PET-MR imaging

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-choline uptake, as marker of plaque inflammation	• To assess on PET the uptake of 18F-choline tracer in the symptomatic carotid artery plaque, given as Target-to-Background uptake Ratio (TBR);	1 year
Primary	correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque	• In case of carotid surgery, 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	1 year
Primary	sensitivity, specificity, negative predictive value of 18F-choline PET	• To determine the sensitivity, specificity, negative predictive value of 18F-choline PET in diagnosis of vulnerable plaques.	1 year
Secondary	Correlation of F18-Choline uptake vs other histologic plaque parameters.	• In case of carotid surgery, 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;	1 year
Secondary	Correlation of F18-Choline uptake vs PET and MRI parameters of atherosclerotic plaque	• To correlate the intra-plaque 18F-choline uptake on PET and MRI parameters of atherosclerotic plaque, such as % of intra-plaque fibrous tissue, lipid core, hemorrhage, calcifications;	1 year
Secondary	Correlation of F18-choline plaque uptake vs 18F-FDG uptake	• To correlate the intra-plaque 18F-choline uptake on PET with the already established FDG PET imaging parameters of atherosclerotic plaque, such as inflammation;	1 year
Secondary	Symptomatic vs asymptomatic F18-Choline uptake	• To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery.	1 year
Secondary	Correlation of F18choline plaque uptake vs cardiovascular risk profile	• To evaluate a possible association between the degree of 18F-choline uptake on PET with patients' cardiovascular risk profile and medical history.	1 year