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

Primary Purpose

Carotid Artery Stenosis

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sodium fluoride F-18 PET imaging
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

symptomatic

asymptomatic

Arm Description

Outcomes

Primary Outcome Measures

carotid F18-NaF uptake
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination

Secondary Outcome Measures

comparaison of F18-NaF PET and Carotid MRI
comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination
F18-NaF PET uptake
comparaison between F18-NaF uptake at pre-operative imaging
histology
comparaison between histology at post-operative histologic analysis

Full Information

First Posted
April 14, 2017
Last Updated
January 9, 2020
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT03353103
Brief Title
Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy
Acronym
CAROTEP
Official Title
Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
symptomatic
Arm Type
Active Comparator
Arm Title
asymptomatic
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sodium fluoride F-18 PET imaging
Intervention Description
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging
Primary Outcome Measure Information:
Title
carotid F18-NaF uptake
Description
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination
Time Frame
baseline
Secondary Outcome Measure Information:
Title
comparaison of F18-NaF PET and Carotid MRI
Description
comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination
Time Frame
baseline
Title
F18-NaF PET uptake
Description
comparaison between F18-NaF uptake at pre-operative imaging
Time Frame
baseline
Title
histology
Description
comparaison between histology at post-operative histologic analysis
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Cameliere, MD
Phone
+33231065161
Email
cameliere-l@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Manrique, MD PhD
Phone
+33231470287
Email
manrique@cyceron.fr
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Camelière
Phone
+33231065161
Email
cameliere-l@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

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