A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma
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.
I. Evaluate the time to tumor progression. II. Evaluate the overall survival.
Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery.
After completion of study treatment, patients are followed up for 2 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Volume of residual enhancing tumor, as determined by intraoperative volume MRI without and with gadolinium, following maximal resection with use of aminolevulinic acid
Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
Michael Vogelbaum, MD, PhD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|