Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
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)
Adult Giant Cell Glioblastoma
Recurrent Adult Brain Tumor
Drug: aminolevulinic acid
Procedure: therapeutic conventional surgery
|Study Design:||Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Primary Completion Date:||December 2013 (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.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Michael A. Vogelbaum, MD, PhD 216-444-8564 email@example.com|
|Principal Investigator: Michael A. Vogelbaum|
|Principal Investigator:||Michael Vogelbaum, MD, PhD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|