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

NCT07731555 | Recruiting DMC

• 1 other identifier: 22-54
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioblastoma

Keywords

Blood Brain Barrier; Glioblastoma; High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury

  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.

  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 Outcomes (4)

• MRI Based Measures of Blood-Brain Barrier Integrity

  4 weeks after surgery

• Immunohistochemical Characterisation of Blood-Brain Barrier Disruption

  During surgical resection (single assessment)

• Transcriptional Characterisation of Blood-Brain Barrier Disruption

  During surgical resection (single assessment)

• Neurocognitive Function Assessed by RBANS

  Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy

Study Arms (1)

Blood Brain Barrier Characterisation Cohort

EXPERIMENTAL

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.

Diagnostic Test: Multimodal Blood Brain Barrier Assessment

Interventions

Multimodal Blood Brain Barrier Assessment DIAGNOSTIC_TEST

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.

Blood Brain Barrier Characterisation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patrick Morris: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, D09, Ireland

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)

CONTACT

018093000; cancerdirectorate@beaumont.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants with newly diagnosed glioblastoma will undergo a standardized multimodal assessment program including advanced MRI imaging, serial blood biomarker sampling, neurocognitive testing, and molecular characterization of tumor tissue obtained during surgical resection. Assessments will be performed longitudinally before and after surgery and following completion of radiotherapy.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director Cancer Clinical Trials Unit

Model Details: Phase 2, single-arm, open label interventional study designed to evaluate blood-brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma. All participants will undergo a standardized intervention schedule consisting of advanced contrast-enhanced MRI, serial blood biomarker assessments, neurocognitive testing, and tumor tissue collection and analysis in conjunction with standard-of-care surgical resection and subsequent treatment. The study will evaluate longitudinal changes in BBB integrity and their association with radiological, molecular, and neurocognitive outcomes across multiple predefined time points from diagnosis through completion of radiotherapy.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2035
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IE (1)