18F-choline PET-CT and MRI of Carotid Plaques

Plaque, Atherosclerotic Clinical Trial

— ParisK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01899014
• Other study ID #: NL43466.068.13
• Secondary ID: 2013-000456-17
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 10, 2013
• Last updated: April 9, 2015
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Plaque, Atherosclerotic

Intervention

Drug:
• 18F-choline PET-CT imaging
18F-choline PET-CT imaging

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Center for Translational Molecular Medicine

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Bucerius J, Schmaljohann J, Böhm 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

Förster 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, Schäfers 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	To correlate the 18F-choline uptake in the atherosclerotic plaque with the degree of intraplaque inflammation, as assessed on histology.		1 year	No
Secondary	To correlate the intra-plaque 18F-choline uptake on PET with other histologic plaque parameters besides inflammation.		1 year	No
Secondary	To correlate the intra-plaque 18F-choline uptake on PET with atherosclerotic plaque parameters assessed on CT, MRI, and ultrasound.		1 year	No
Secondary	To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery.		1 year	No
Secondary	To evaluate a possible association between the degree of 18F-choline uptake on PET with patients' cardiovascular risk profile and medical history.		1 year	No

External Links

•   CTMM project
•   ParisK study