Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
Overview
- Phase
- Not Applicable
- Intervention
- 18F-sodium fluoride PET/MR
- Conditions
- Carotid Artery Plaque
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
Intervention: 18F-sodium fluoride PET/MR
control
Patients with asymptomatic carotid plaque ≥ 50%
Intervention: 18F-sodium fluoride PET/MR
Outcomes
Primary Outcomes
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Time Frame: at day 0 in asymptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Time Frame: during the last 15 days in symptomatic patients
Secondary Outcomes
- Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.(at day 0 in asymptomatic patients)
- Number of participants with histological image of intraplaque hemorrhage, and/or lipid-rich necrotic core and /or thinning/rupture of the fibrous cap in surgical patients.(during the last 15 days in symptomatic patients)
- Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)(at Day 0)
- Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.(at day 0 in asymptomatic patients)
- Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.(at day 0 in asymptomatic patients)
- Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.(at day 0 in asymptomatic patients)
- Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.(during the last 15 days in symptomatic patients)