Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01608516
Recruitment Status : Recruiting
First Posted : May 31, 2012
Last Update Posted : November 15, 2016
Swiss Heart Foundation
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Inflammation Atheromatous Plaques Carotid Artery Diseases Radiation: 68Ga-NODAGA-RGD PET/CT Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
Study Start Date : April 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608516

Contact: John O. Prior, PhD, MD +41 21 314 43 48
Contact: Emmanuel Deshayes, MD +41 21 314 02 20

Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Swiss Heart Foundation
Principal Investigator: John O. Prior, PhD, MD Lausanne University Hospitals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: John O. Prior, Chief of Department of Nuclear Medicine, University of Lausanne Hospitals Identifier: NCT01608516     History of Changes
Other Study ID Numbers: 80/10
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John O. Prior, University of Lausanne Hospitals:
US ultrasound
inflammatory atheromatous plaque

Additional relevant MeSH terms:
Carotid Artery Diseases
Plaque, Atherosclerotic
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action