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Идёт набор NCT06079294

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

Без фазы С лечением Autoimmune Encephalitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FDG PET.
Кому может быть актуально
Состояния в реестре: Autoimmune Encephalitis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study

Обзор

Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.

Подробное описание

Autoimmune encephalitis is a diagnostic challenge, and requires early diagnosis for improved neurological outcomes. FDG PET has shown very high sensitivity, suggesting better performances than MRI, but almost exclusively in small sized retrospective studies. Brain FDG PET is therefore not included in current diagnostic criteria, conversely to brain MRI. This study will include 56 patients with confirmed - seropositive or seronegative - autoimmune encephalitis, based on 2016 Graus criteria for autoimmune encephalitis and 2021 criteria for paraneoplastic neurological syndromes. The main objective is to conduct a prospective evaluation of the diagnostic value of FDG PET performed in the acute phase before treatment initiation, or within 10 days of treatment initiation. A follow-up PET performed 3 months after treatment initiation will also be performed and analysed for all patients as part of secondary objective analyses.

Вмешательства

  • Другое FDG PET
    Brain FDG PET performed 3 months after treatment initiation

Первичные конечные точки

  • Main analysis of initial brain FDG PET [Срок оценки: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)]
Вторичные конечные точки (6)
  • Analysis of follow-up brain FDG PET [Срок оценки: PET performed 3 months after treatment initiation, compared to initial brain PET]
  • Secondary analysis of initial brain FDG PET [Срок оценки: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)]
  • Secondary analysis of initial brain FDG PET [Срок оценки: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)]
  • Secondary analysis of initial brain FDG PET [Срок оценки: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)]
  • Secondary analysis of initial and follow-up brain FDG PET [Срок оценки: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation), and follow-up PET 3 months after treatment initiation]
  • Analysis of initial whole body FDG PET [Срок оценки: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)]

Критерии участия

Критерии включения

  • Age ≥ 18 years old
  • Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :
  • " Definite limbic autoimmune encephalitis " according to 2016 Graus et al. criteria
  • " Possible autoimmune encephalitis " according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF
  • " Probable or certain paraneoplastic neurological syndrome " according to Graus et al. 2021 criteria (excluding peripheral neurological syndromes)
  • Less than 6 months since first neurological symptoms imputable to autoimmune encephalitis
  • Affiliated or entitled to a social security system (except AME)
  • Obtaining free, written and informed consent (patient or legal representative or the close relative)

Критерии исключения

  • History of brain tumor, head trauma, infarction or cerebral hematoma likely to result in altered cerebral carbohydrate metabolism on PET
  • Patients who hae been on immunotherapy (corticosteroid bolus, IVIg, plasma exchange, endoxan, rituximab or other immunotherapy) fr more than 10 days
  • Pregnant or breast-feeding woman
  • Ventilated intubated patient
  • Absolute contraindication to MRI (Pacemaker, cochlear implant, etc.)
  • Presence of cognitive disorders incompatible with goog cooperation with the PET scan
  • Algic or agitated patient unable to remain immobile in supine position for 30 minutes
  • Deprived of liberty or under a protective measure (guardianship or curatorship)
  • Patient taking part in other interventional research involving radiopharmaceutical injections

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Hospital Pitie Salpetriere — Paris

Идентификаторы

NCT: NCT06079294 · APHP221163

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗