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Molecular Imaging of Plaque Vulnerability (PARISK)

Primary Purpose

Plaque, Atherosclerotic

Status

Recruiting

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

18F-choline PET-MR imaging

Sponsored by

Maastricht University Medical Center

About this trial

This is an interventional diagnostic trial for Plaque, Atherosclerotic focused on measuring 18F-fluormethylcholine, [F18] choline, [F18] fluormethylcholine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

Maastricht University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-choline PET-MR imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

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);

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

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.

Secondary Outcome Measures

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;

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;

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;

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.

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.

Full Information

NCT ID

First Posted

December 22, 2015

Last Updated

October 23, 2023

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02640313

Brief Title

Molecular Imaging of Plaque Vulnerability

Acronym

PARISK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 2015 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque, Atherosclerotic

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-choline PET-MR imaging

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

18F-choline PET-MR imaging

Other Intervention Name(s)

PET-MRI

Intervention Description

Dynamic and static 18F-choline PET-MR imaging

Primary Outcome Measure Information:

Title

18F-choline uptake, as marker of plaque inflammation

Description

• To assess on PET the uptake of 18F-choline tracer in the symptomatic carotid artery plaque, given as Target-to-Background uptake Ratio (TBR);

Time Frame

1 year

Title

correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque

Description

• 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

Time Frame

1 year

Title

sensitivity, specificity, negative predictive value of 18F-choline PET

Description

• To determine the sensitivity, specificity, negative predictive value of 18F-choline PET in diagnosis of vulnerable plaques.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Description

• 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;

Time Frame

1 year

Title

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

Description

• 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;

Time Frame

1 year

Title

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

Description

• To correlate the intra-plaque 18F-choline uptake on PET with the already established FDG PET imaging parameters of atherosclerotic plaque, such as inflammation;

Time Frame

1 year

Title

Symptomatic vs asymptomatic F18-Choline uptake

Description

• To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery.

Time Frame

1 year

Title

Correlation of F18choline plaque uptake vs cardiovascular risk profile

Description

• To evaluate a possible association between the degree of 18F-choline uptake on PET with patients' cardiovascular risk profile and medical history.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jochem van der Pol, MD

Phone

+31 43 38 74746

Email

jochem.vander.pol@mumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M. Eline Kooi, PhD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jochem van der Pol, MD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Vöö, MD, PhD

Phone

+31 43 38 74746

Email

stefan.voo@mumc.nl

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

18183393

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.

Results Reference

background

PubMed Identifier

20532464

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.

Results Reference

background

PubMed Identifier

19430785

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.

Results Reference

background

PubMed Identifier

27162131

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.

Results Reference

derived

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Molecular Imaging of Plaque Vulnerability

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