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

10. Juli 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

15

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
Arzneimittel: 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%
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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)
Zeitfenster: at Day 0
at Day 0

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hospices Civils de Lyon

Ermittler

  • Hauptermittler: Norbert NIGHOGHOSSIAN, Pr, Hospices Civils de Lyon

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Januar 2016

Primärer Abschluss (Tatsächlich)

12. Dezember 2017

Studienabschluss (Tatsächlich)

12. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

15. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. März 2016

Zuerst gepostet (Schätzen)

4. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juli 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2018

Zuletzt verifiziert

1. Juli 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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