Molecular Imaging of Plaque Vulnerability

NCT ID: NCT02640313

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2024-03-01

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.

Conditions

Plaque, Atherosclerotic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-choline PET-MR imaging

Intervention: 18F-choline PET-MR imaging.

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-MR.

Group Type: EXPERIMENTAL

18F-choline PET-MR imaging

Intervention Type: DRUG

Dynamic and static 18F-choline PET-MR imaging

Interventions

18F-choline PET-MR imaging

Dynamic and static 18F-choline PET-MR imaging

Intervention Type: DRUG

Other Intervention Names

PET-MRI

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Eline Kooi, PhD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Jochem van der Pol, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jochem van der Pol, MD

Role: CONTACT

jochem.vander.pol@mumc.nl

+31 43 38 74746

Facility Contacts

Stefan Vöö, MD, PhD

Role: primary

stefan.voo@mumc.nl

+31 43 38 74746

References

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.

Reference Type: BACKGROUND

PMID: 18183393 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20532464 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19430785 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27162131 (View on PubMed)

Other Identifiers

NL43466.068.13/ABR43466

Identifier Type: -

Identifier Source: org_study_id

NCT01899014

Identifier Type: -

Identifier Source: nct_alias