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

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ClinicalTrials.gov Identifier: NCT02726984
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Carotid Artery Plaque Drug: 18F-sodium fluoride PET/MR

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
Actual Study Start Date : January 15, 2016
Primary Completion Date : December 12, 2017
Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Measure of SUV (standardized uptake value) among carotid plaques ≥ 50% [ Time Frame: during the last 15 days in symptomatic patients ]
  2. Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50% [ Time Frame: at day 0 in asymptomatic patients ]
  3. Measure of SUV (standardized uptake value) among carotid plaques ≥ 50% [ Time Frame: at day 0 in asymptomatic patients ]
  4. Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50% [ Time Frame: during the last 15 days in symptomatic patients ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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).

  9. 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 ]
  10. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726984


Locations
France
Hospices Civils de Lyon
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Norbert NIGHOGHOSSIAN, Pr Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02726984     History of Changes
Other Study ID Numbers: 69HCL15_0283
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
stroke
carotid plaque
18F-sodium fluoride PET/MR

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents