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

10 de julho de 2018 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

15

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • França
      • Bron, França, 69500
        • Hospices Civils de Lyon

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
Medicamento: 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%
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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 thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: during the last 15 days in symptomatic 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)
Prazo: at Day 0
at Day 0

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospices Civils de Lyon

Investigadores

  • Investigador principal: Norbert NIGHOGHOSSIAN, Pr, Hospices Civils de Lyon

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de janeiro de 2016

Conclusão Primária (Real)

12 de dezembro de 2017

Conclusão do estudo (Real)

12 de dezembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

15 de dezembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de março de 2016

Primeira postagem (Estimativa)

4 de abril de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de julho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de julho de 2018

Última verificação

1 de julho de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 69HCL15_0283
  • 2015-002327-26 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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