Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

Carotid Artery Stenosis Clinical Trial

— CAROTEP  

Official title:

Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03353103
• Other study ID #: 17-012
• Status: Recruiting
• Phase: Phase 2
• Start date: September 3, 2018
• Est. completion date: June 2021

Study information

• Verified date: January 2020
• Source: University Hospital, Caen
• Contact: Lucie Cameliere, MD
• Phone: +33231065161
• Email: cameliere-l[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid F18-NaF uptake	do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination	baseline
Secondary	comparaison of F18-NaF PET and Carotid MRI	comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination	baseline
Secondary	F18-NaF PET uptake	comparaison between F18-NaF uptake at pre-operative imaging	baseline
Secondary	histology	comparaison between histology at post-operative histologic analysis	baseline