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

Caen University Hospital

Status and phase: Unknown; Phase 2

Conditions: Carotid Artery Stenosis

Treatments: Drug: Sodium fluoride F-18 PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03353103

17-012

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

symptomatic

Active Comparator group

Treatment:

Drug: Sodium fluoride F-18 PET imaging

asymptomatic

Active Comparator group

Treatment:

Drug: Sodium fluoride F-18 PET imaging