Clinical trial · Interventional
Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Blood Brain Barrier Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood Brain Barrier Characterisation Cohort
- description
- 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.
- interventionNames
- Diagnostic Test: Multimodal Blood Brain Barrier Assessment
Primary outcomes (1)
- measure
- Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available