Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

Phase 2

• Conditions: Carotid Artery Stenosis
• Interventions: Drug: Sodium fluoride F-18 PET imaging

• Registration Number: NCT03353103
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-27
• Study Start: 2018-09-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
symptomatic	Sodium fluoride F-18 PET imaging	-
asymptomatic	Sodium fluoride F-18 PET imaging	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France