Molecular Imaging of Plaque Vulnerability

NCT02640313 | Unknown Phase 3 DMC

• 1 other identifier: NL43466.068.13/ABR43466
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque, Atherosclerotic

Keywords

18F-fluormethylcholine; [F18] choline; [F18] fluormethylcholine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Correlation of F18-Choline uptake vs other histologic plaque parameters.

  1 year

• Correlation of F18-Choline uptake vs PET and MRI parameters of atherosclerotic plaque

  1 year

• Correlation of F18-choline plaque uptake vs 18F-FDG uptake

  1 year

• Symptomatic vs asymptomatic F18-Choline uptake

  1 year

• Correlation of F18choline plaque uptake vs cardiovascular risk profile

  1 year

Study Arms (1)

18F-choline PET-MR imaging

EXPERIMENTAL

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.

Drug: 18F-choline PET-MR imaging

Interventions

18F-choline PET-MR imaging DRUG

Dynamic and static 18F-choline PET-MR imaging

Also known as: PET-MRI

18F-choline PET-MR imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 18183393 BACKGROUND

• 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.

  PMID: 20532464 BACKGROUND

• 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.

  PMID: 19430785 BACKGROUND

• 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.

  PMID: 27162131 DERIVED

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• M. Eline Kooi, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

• Jochem van der Pol, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochem van der Pol, MD

CONTACT

+31 43 38 74746; jochem.vander.pol@mumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)