Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
25 de julho de 2026 atualizado 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
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
100
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.
Contato de estudo
- Nome: Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)
- Número de telefone: 018093000
- E-mail: cancerdirectorate@beaumont.ie
Locais de estudo
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Beaumont, Irlanda, D09
- Recrutamento
- Beaumont RCSI Cancer Centre
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Contato:
- Aisling Hegarty, RGN, BSc, MSc, PhD
- Número de telefone: 017977800
- E-mail: Aislinghegarty@rcsi.ie
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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MRI Based Measures of Blood-Brain Barrier Integrity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
1 de março de 2022
Conclusão Primária (Estimado)
31 de dezembro de 2029
Conclusão do estudo (Estimado)
31 de dezembro de 2035
Datas de inscrição no estudo
Enviado pela primeira vez
22 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de julho de 2026
Primeira postagem (Real)
28 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 22-54
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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