Adult Glioblastoma Clinical Trial
Official title:
A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma
The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)
PRIMARY OBJECTIVES:
I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a
glioblastoma multiforme (GBM).
II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated
on a pre-operative MRI.
SECONDARY OBJECTIVES:
I. Evaluate the time to tumor progression. II. Evaluate the overall survival.
OUTLINE:
Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery.
After completion of study treatment, patients are followed up for 2 weeks.
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