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NCT07731555

Overview

NCT ID: NCT07731555
Lead Sponsor: Patrick MorrisOTHER
Official Title: Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Mar 1, 2022Actual
Primary Completion Date: Dec 31, 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 100Estimated
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)Contact
cancerdirectorate@beaumont.ie

Similar Studies

Participant Group/Arms

Blood Brain Barrier Characterisation CohortExperimental

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