Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients. The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).

Trial Details

NCT ID
NCT05954858
Phase
NA
Sponsor
Northwell Health
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Subject is a male or female 18 years of age or older.
  • Subject is undergoing planned resection of known or suspected GBM.
  • Subject has a Karnofsky Performance Status (KPS) 70% or greater.
  • Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.

For full eligibility, visit ClinicalTrials.gov.

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