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Идёт набор NCT07731555

Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses

Без фазы С лечением Glioblastoma

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: Multimodal Blood Brain Barrier Assessment.
Кому может быть актуально
Состояния в реестре: Glioblastoma. 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
Ирландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This prospective study aims to characterize blood brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma multiforme undergoing surgical resection. The study integrates advanced MRI, circulating BBB biomarkers, neurocognitive assessment, and molecular analysis of tumor tissue to investigate relationships between BBB integrity, tumor biology, and neurological function. Participants will undergo serial assessments before surgery, after surgery, and following radiotherapy. Tumor tissue collected during standard-of-care resection will undergo immunohistochemical and transcriptional

Подробное описание

Glioblastoma is characterized by disruption of the blood-brain barrier, which may influence tumor progression, neurological dysfunction, treatment delivery, and clinical outcomes. This study seeks to comprehensively characterize BBB integrity using multimodal approaches.

Participants with newly diagnosed GBM selected for surgical resection will undergo:

* Clinical and demographic data collection. * Neurocognitive assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Reading the Mind in the Eyes Test (RMET). * High-resolution 3-Tesla MRI with and without gadolinium contrast, including structural and functional imaging sequences. * Blood sampling for measurement of biomarkers associated with BBB disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase. * Collection of tumor tissue during routine surgical resection for immunohistochemical and transcriptional analyses.

Serial evaluations will be performed preoperatively, postoperatively, at 72 hours, at 4 weeks, and 4 weeks following completion of radiotherapy, according to the assessment schedule.

Вмешательства

  • Диагностический тест Multimodal Blood Brain Barrier Assessment
    A standardised multimodal diagnostic assessment designed to characterize blood brain barrier integrity in patients with newly diagnosed glioblastoma. The intervention includes advanced contrast enhanced MRI, serial blood sampling for measurement of blood-brain barrier and neuronal injury biomarkers (including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase), neurocognitive assessments, and immunohistochemical and transcriptional analyses of tumor tissue obtained

Первичные конечные точки

  • Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury [Срок оценки: Baseline (within 7 days before surgery), intraoperative, within 24 hours after surgery, 72 hours after surgery, 4 weeks after surgery, and 4 weeks after completion of radiotherapy]
Вторичные конечные точки (4)
  • MRI Based Measures of Blood-Brain Barrier Integrity [Срок оценки: 4 weeks after surgery]
  • Immunohistochemical Characterisation of Blood-Brain Barrier Disruption [Срок оценки: During surgical resection (single assessment)]
  • Transcriptional Characterisation of Blood-Brain Barrier Disruption [Срок оценки: During surgical resection (single assessment)]
  • Neurocognitive Function Assessed by RBANS [Срок оценки: Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy]

Критерии участия

Критерии включения

  • Adult patients aged 18 years or older.
  • Newly diagnosed glioblastoma.
  • Selected for surgical tumor resection.
  • Able and willing to provide written informed consent.
  • Able to undergo study assessments and follow-up procedures.

Критерии исключения

  • Contraindication to magnetic resonance imaging.
  • Confusion, delirium, or altered state of consciousness that interferes with the ability to provide informed consent.
  • Any condition that, in the opinion of the investigator, would prevent completion of study procedures or compromise participant safety.

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
Диагностика

Центры проведения

Ирландия · 1 центр
  • Beaumont RCSI Cancer Centre — Beaumont

Идентификаторы

NCT: NCT07731555 · 22-54

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗