- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726984
Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR (CARTIS)
July 10, 2018 updated by: Hospices Civils de Lyon
Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bron, France, 69500
- Hospices Civils de Lyon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
|
18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm.
18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before.
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Experimental: control
Patients with asymptomatic carotid plaque ≥ 50%
|
18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm.
18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Time Frame: during the last 15 days in symptomatic patients
|
during the last 15 days in symptomatic patients
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Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Time Frame: at day 0 in asymptomatic patients
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at day 0 in asymptomatic patients
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Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Time Frame: at day 0 in asymptomatic patients
|
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
|
during the last 15 days in symptomatic patients
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: during the last 15 days in symptomatic 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.
|
during the last 15 days in symptomatic patients
|
Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
Time Frame: during the last 15 days in symptomatic 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.
|
during the last 15 days in symptomatic patients
|
Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
Time Frame: during the last 15 days in symptomatic 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.
|
during the last 15 days in symptomatic patients
|
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.
Time Frame: 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.
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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.
Time Frame: 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.
|
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.
Time Frame: 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).
|
during the last 15 days in symptomatic patients
|
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.
Time Frame: 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).
|
at day 0 in asymptomatic patients
|
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
Time Frame: 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).
|
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.
Time Frame: during the last 15 days in symptomatic patients
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during the last 15 days in symptomatic patients
|
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Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)
Time Frame: at Day 0
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at Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Norbert NIGHOGHOSSIAN, Pr, Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2016
Primary Completion (Actual)
December 12, 2017
Study Completion (Actual)
December 12, 2017
Study Registration Dates
First Submitted
December 15, 2015
First Submitted That Met QC Criteria
March 29, 2016
First Posted (Estimate)
April 4, 2016
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Carotid Artery Diseases
- Carotid Stenosis
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Protective Agents
- Cariostatic Agents
- Listerine
- Fluorides
- Sodium Fluoride
Other Study ID Numbers
- 69HCL15_0283
- 2015-002327-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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