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Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy (CAROTEP)

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: NCT03353103
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Drug: Sodium fluoride F-18 PET imaging Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: symptomatic Drug: Sodium fluoride F-18 PET imaging
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

Active Comparator: asymptomatic Drug: Sodium fluoride F-18 PET imaging
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

Primary Outcome Measures :
  1. carotid F18-NaF uptake [ Time Frame: baseline ]
    do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination

Secondary Outcome Measures :
  1. comparaison of F18-NaF PET and Carotid MRI [ Time Frame: baseline ]
    comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination

  2. F18-NaF PET uptake [ Time Frame: baseline ]
    comparaison between F18-NaF uptake at pre-operative imaging

  3. histology [ Time Frame: baseline ]
    comparaison between histology at post-operative histologic analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18 years old
  • Health care system affiliation
  • Referred to carotid endarterectomy
  • Symptomatic patients:

    • Carotid stenosis between 70 and 99% (NASCET criteria)
    • TIA or minor stroke attack (RANKIN ≤ 3)
  • Asymptomatic patients:

    • Carotid stenosis between 70 and 99% (NASCET criteria)
    • No symptoms
  • Patient who has been informed of the study and has given his/her informed consent

Exclusion Criteria:

  • Contra indication to MRI
  • Renal failure (clearance < 30ml/mn)
  • Patient with active inflammatory disease
  • History of cancer
  • Pregnancy or lactation
  • Patient with carotid disease treated by fibrinolysis
  • Patient under guardianship, or unable to understand the purpose of the study

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): NCT03353103

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Contact: Lucie Cameliere, MD +33231065161
Contact: Alain Manrique, MD PhD +33231470287

Sponsors and Collaborators
University Hospital, Caen
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Study Chair: Christophe Kassel University Hospital, Caen

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Responsible Party: University Hospital, Caen Identifier: NCT03353103     History of Changes
Other Study ID Numbers: 17-012
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sodium Fluoride
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents