Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03353103

Acronym

CAROTEP

Enrollment

Registered

2017-11-27

Start date

2018-09-03

Completion date

2021-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis

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

Interventions

DRUGSodium fluoride F-18 PET imaging

prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

Primary ContactLucie Cameliere, MD

cameliere-l@chu-caen.fr+33231065161

Backup ContactAlain Manrique, MD PhD

manrique@cyceron.fr+33231470287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026