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

Not Applicable

Completed

• Conditions: Carotid Artery Plaque
• Interventions: Drug: 18F-sodium fluoride PET/MR

• Registration Number: NCT02726984
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-12-15
• Study Start: 2016-01-15
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Primary Completion: 2017-12-12
• Study Completion: 2017-12-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	18F-sodium fluoride PET/MR	Patients with asymptomatic carotid plaque ≥ 50%
case	18F-sodium fluoride PET/MR	Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days

Primary Outcome Measures

Name	Time	Method
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%	at day 0 in asymptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%	during the last 15 days in symptomatic patients

Secondary Outcome Measures

Name	Time	Method
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.	at day 0 in asymptomatic patients	Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D. An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
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	identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
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	identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.	at day 0 in asymptomatic patients	Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D. An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
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	Quantitative assessement of the wall shear stresses (WSS, measured in Pa) and oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D. An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France