Clinical trial NCT02726984: Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR
Official title: Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Plaque
Keywords: stroke
carotid plaque
18F-sodium fluoride PET/MR
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
timeFrame: during the last 15 days in symptomatic patients
measure: Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
timeFrame: at day 0 in asymptomatic patients
measure: Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
timeFrame: at day 0 in asymptomatic patients
measure: Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
timeFrame: during the last 15 days in symptomatic patients
Secondary outcomes:
measure: 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.
timeFrame: during the last 15 days in symptomatic patients
measure: Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
timeFrame: during the last 15 days in symptomatic patients
measure: Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
timeFrame: during the last 15 days in symptomatic patients
measure: 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.
timeFrame: at day 0 in asymptomatic patients
measure: Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
timeFrame: at day 0 in asymptomatic patients
measure: Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
timeFrame: during the last 15 days in symptomatic patients
measure: Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.
timeFrame: at day 0 in asymptomatic patients
measure: Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
timeFrame: at day 0 in asymptomatic patients
measure: 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.
timeFrame: during the last 15 days in symptomatic patients
measure: Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)
timeFrame: at Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Norbert NIGHOGHOSSIAN, Pr
role: PRINCIPAL_INVESTIGATOR
References: