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Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

This study is currently recruiting participants.
Verified November 2016 by John O. Prior, University of Lausanne Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608516
First Posted: May 31, 2012
Last Update Posted: November 15, 2016
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.
Collaborator:
Swiss Heart Foundation
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by John O. Prior, University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01608516


Contacts
Contact: John O. Prior, PhD, MD +41 21 314 43 48 john.prior@chuv.ch
Contact: Emmanuel Deshayes, MD +41 21 314 02 20 emmanuel.deshayes@chuv.ch

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

Responsible Party: John O. Prior, Chief of Department of Nuclear Medicine, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01608516     History of Changes
Other Study ID Numbers: 80/10
First Submitted: April 16, 2012
First Posted: May 31, 2012
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:
PET/CT
68Ga-NODAGA-RGD
18F-FDG
MRI
US ultrasound
inflammatory atheromatous plaque
endarterectomy

Additional relevant MeSH terms:
Inflammation
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
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action