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Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

This study is currently recruiting participants.
Verified May 2012 by University of Lausanne Hospitals
Sponsor:
Collaborator:
Swiss Heart Foundation
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01608516
First received: April 16, 2012
Last updated: May 28, 2012
Last verified: May 2012
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • 68Ga-NODAGA-RGD PET/CT [ Time Frame: day -1 before planned endarterectomy ] [ Designated as safety issue: Yes ]

    60 minutes after radiotracer injection, images centred on the carotid area will be acquired and SUVmax, SUV90%carotids/SUVbackground measured.

    The 5 first patients/20 will have a total body imaging acquisition for tracer biodistribution assessment and dosimetric study.



Secondary Outcome Measures:
  • US Doppler with microbubbles [ Time Frame: day -6 to day -2 before planned endarterectomy ] [ Designated as safety issue: No ]
    gray scale median analysis

  • 18F-FDG PET/CT [ Time Frame: day -6 to day -2 before planned endarterectomy ] [ Designated as safety issue: No ]
    45 minutes after radiotracer injection, images centred on the carotid area will be acquired and SUVmax, SUV90%carotids/SUVbackground measured

  • MRI [ Time Frame: day -1 before planned endarterectomy ] [ Designated as safety issue: No ]
    MRI images centred on the carotid area will be acquired using sequences before and after gadolinium administration

  • Histopathology [ Time Frame: within 1 month of endarterectomy ] [ Designated as safety issue: No ]
    Degree of local inflammation measured by macrophagic infiltration on anti-CD68 IHC coloration and degree of neovascularization on HES coloration.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 68Ga-NODAGA-RGD radiotracer
68Ga-NODAGA-RGD PET/CT
 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 16, 2012
Last Updated: May 28, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Lausanne Hospitals:
PET/CT
68Ga-NODAGA-RGD
18F-FDG
MRI
 US ultrasound
inflammatory atheromatous plaque
endarterectomy

Additional relevant MeSH terms:
Carotid Artery Diseases
Inflammation
Plaque, Atherosclerotic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013