Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

July 13, 2023 updated by: John O. Prior, University of Lausanne Hospitals

Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US

The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.

Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation.

All imaging results and histopathology results will be pooled and compared.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

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 Contact Backup

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age <= 85 years
  • Karnofsky >= 80%
  • patient with indication ofr carotid endarterectomy
  • signed consent form

Exclusion Criteria:

  • indication for surgery other than endarterectomy <14 days
  • contraindication to surgery
  • contraindication to MRI
  • contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR<30ml/min/1.73m2)
  • pregnancy, breastfeeding
  • lack of discernment

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: 68Ga-NODAGA-RGD radiotracer
All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US.
Radiation: 68Ga-NODAGA-RGD PET/CT
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
Time Frame: Within1 month of endarterectomy
The potential of each of the methods of imaging for the detection of inflammatory atheromatous plaques will be compared. For that purpose, the capacity of every criterion of primary assessment to determine the presence of an unstable plaque will be studied compared with the histopathological sample.
Within1 month of endarterectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of AUC of the imaging methods
Time Frame: Within1 month of endarterectomy
A comparison of the AUC will be realized to determine the superiority of a method compared with the other one, by a non parametric test comparing AUC , ROC curves respectively.
Within1 month of endarterectomy
Analysis of histopathological sample of endarterectomy
Time Frame: Within1 month of endarterectomy
The histopathological analysis will be the degree of local inflammation estimated by the macrophagic infiltration as well as the degree of neovascularization.
Within1 month of endarterectomy

Collaborators and Investigators

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

Sponsor

University of Lausanne Hospitals

Collaborators

Swiss Heart Foundation

Investigators

  • Principal Investigator: John O. Prior, PhD, MD, Lausanne University Hospitals

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.

General Publications

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)

April 1, 2012

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

May 28, 2012

First Posted (Estimated)

May 31, 2012

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80/10

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.

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