Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
25 de julio de 2026 actualizado por: Patrick Morris
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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)
- Número de teléfono: 018093000
- Correo electrónico: cancerdirectorate@beaumont.ie
Ubicaciones de estudio
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Beaumont, Irlanda, D09
- Reclutamiento
- Beaumont RCSI Cancer Centre
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Contacto:
- Aisling Hegarty, RGN, BSc, MSc, PhD
- Número de teléfono: 017977800
- Correo electrónico: Aislinghegarty@rcsi.ie
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Blood Brain Barrier Characterisation Cohort
Participants with newly diagnosed glioblastoma will undergo a standardized Phase 2 multimodal assessment program designed to characterize blood-brain barrier integrity.
Study interventions include serial advanced contrast-enhanced MRI, blood biomarker sampling, neurocognitive assessments, and molecular analysis of tumor tissue obtained during standard of care surgical resection.
Assessments will be performed longitudinally at predefined time points before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy to evaluate changes in blood-brain barrier function and their association with clinical, radiological, and molecular outcomes.
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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 during standard-of-care surgical resection.
Assessments are performed longitudinally before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
Periodo de tiempo: 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
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Serial measurement of serum biomarkers associated with blood-brain barrier disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase.
Biomarker concentrations will be assessed longitudinally to characterize changes in blood-brain barrier integrity in patients with newly diagnosed glioblastoma undergoing surgical resection and radiotherapy.
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MRI Based Measures of Blood-Brain Barrier Integrity
Periodo de tiempo: 4 weeks after surgery
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Assessment of blood-brain barrier disruption using contrast-enhanced 3-Tesla MRI, including quantitative and qualitative radiological measures of tumour enhancement and permeability.
Imaging findings will be evaluated longitudinally and correlated with circulating biomarkers and clinical outcomes.
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4 weeks after surgery
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Immunohistochemical Characterisation of Blood-Brain Barrier Disruption
Periodo de tiempo: During surgical resection (single assessment)
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Expression of blood-brain barrier-associated proteins within resected glioblastoma tissue assessed by immunohistochemical analysis.
Findings will be used to characterize blood-brain barrier integrity and correlated with circulating biomarker and imaging measures.
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During surgical resection (single assessment)
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Transcriptional Characterisation of Blood-Brain Barrier Disruption
Periodo de tiempo: During surgical resection (single assessment)
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Gene expression profiling of resected glioblastoma tissue to identify transcriptional signatures associated with blood-brain barrier disruption and tumour biology.
Results will be correlated with blood biomarker and imaging findings.
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During surgical resection (single assessment)
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Neurocognitive Function Assessed by RBANS
Periodo de tiempo: Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy
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Neurocognitive performance measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Changes in cognitive function will be examined in relation to blood-brain barrier integrity and treatment.
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Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2022
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2035
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de julio de 2026
Publicado por primera vez (Actual)
28 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 22-54
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
De-identified individual participant data underlying the results reported in publications arising from this study may be shared with qualified researchers upon reasonable request, subject to approval by the study investigators, institutional policies, ethical approvals, and applicable data protection regulations.
Data sharing will include relevant clinical, imaging, biomarker, and neurocognitive datasets necessary to support replication of study findings.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .