Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR (CARTIS)

Civil Hospices of Lyon

Status: Completed

Conditions: Carotid Artery Plaque

Treatments: Drug: 18F-sodium fluoride PET/MR

Study type: Interventional

Funder types: Other

Identifiers

NCT02726984

69HCL15_0283

2015-002327-26 (EudraCT Number)

Details and patient eligibility

About

Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke. Identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment. The aim of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study. Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and tissue-to-background ratio (TBR) will be measured among carotid plaques.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria symptomatic patients:

• age>18
• Carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days or asymptomatic
• ability to give informed consent
• affiliation to social security

Exclusion Criteria:

• Modified Rankin score ˃ 3
• Contraindication to MRI
• Renal failure (creatinine clearance by cockcroft ˂ 50 ml / min)
• Pregnancy / Breastfeeding
• Hypersensitivity to the active substance or excipients

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

case

Experimental group

Description:

Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days

Treatment:

Drug: 18F-sodium fluoride PET/MR

control

Experimental group

Description:

Patients with asymptomatic carotid plaque ≥ 50%

Treatment:

Drug: 18F-sodium fluoride PET/MR