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Recruiting NCT07731555

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

No phase Interventional Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal Blood Brain Barrier Assessment.
Who it may be relevant to
Registry conditions: Glioblastoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury [Time frame: 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]
Secondary outcome measures (4)
  • MRI Based Measures of Blood-Brain Barrier Integrity [Time frame: 4 weeks after surgery]
  • Immunohistochemical Characterisation of Blood-Brain Barrier Disruption [Time frame: During surgical resection (single assessment)]
  • Transcriptional Characterisation of Blood-Brain Barrier Disruption [Time frame: During surgical resection (single assessment)]
  • Neurocognitive Function Assessed by RBANS [Time frame: Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Ireland · 1 center
  • Beaumont RCSI Cancer Centre — Beaumont

Identifiers

NCT: NCT07731555 · 22-54

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗