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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
Beaumont RCSI Cancer Centre
RECRUITING
Beaumont
Contact Information
Primary
Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)
cancerdirectorate@beaumont.ie
018093000
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: Patrick Morris

This content was sourced from clinicaltrials.gov