Molecular Imaging of Plaque Vulnerability (PARISK)

October 23, 2023 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

Dynamic and static 18F-choline PET-MR imaging
Other Names:
  • PET-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18F-choline uptake, as marker of plaque inflammation
Time Frame: 1 year
• 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
Time Frame: 1 year
• 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
Time Frame: 1 year
• To determine the sensitivity, specificity, negative predictive value of 18F-choline PET in diagnosis of vulnerable plaques.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of F18-Choline uptake vs other histologic plaque parameters.
Time Frame: 1 year
• 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
Correlation of F18-Choline uptake vs PET and MRI parameters of atherosclerotic plaque
Time Frame: 1 year
• 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
Correlation of F18-choline plaque uptake vs 18F-FDG uptake
Time Frame: 1 year
• 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
Symptomatic vs asymptomatic F18-Choline uptake
Time Frame: 1 year
• To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery.
1 year
Correlation of F18choline plaque uptake vs cardiovascular risk profile
Time Frame: 1 year
• To evaluate a possible association between the degree of 18F-choline uptake on PET with patients' cardiovascular risk profile and medical history.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: M. Eline Kooi, PhD, Maastricht University Medical Center
  • Principal Investigator: Jochem van der Pol, MD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimated)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plaque, Atherosclerotic

Clinical Trials on 18F-choline PET-MR imaging

3
Subscribe