Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor||Drug: aminolevulinic acid Procedure: therapeutic conventional surgery||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma|
- Volume of residual enhancing tumor, as determined by intraoperative volume MRI without and with gadolinium, following maximal resection with use of aminolevulinic acid [ Time Frame: Day 1 ]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).
- Comparison between the volume of resected tissue (defined as the volume of the resection cavity) and the pre-operative enhancing tumor volume [ Time Frame: Up to day 1 ]Volume of enhancing tumor (initial and residual) will be determined by use of a software-based 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).
- Time to disease progression (TTP), determined by review of MRIs performed post operatively as clinically indicated, evaluated with use of the new international criteria proposed by the Response in NeuroOncology (RANO) Committee [ Time Frame: From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year ]
- Overall survival, by periodic follow up review of the patient charts and by correlation with the Social Security Death Index [ Time Frame: From the date of surgery with aminolevulinic acid to the date of death, assessed up to 1 year ]
|Study Start Date:||May 2012|
|Study Completion Date:||August 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Diagnostic (aminolevulinic acid)
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
Drug: aminolevulinic acid
Other Names:Procedure: therapeutic conventional surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575275
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Michael Vogelbaum, MD, PhD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|