Study:
A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma
Rationale:
n/a
Purpose:
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)
Study Status: Recruiting
Recruiting:
Michael A. Vogelbaum, MD, PhD 216-444-8564 vogelbm@ccf.org
| Condition |
Intervention |
Phase |
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor |
Drug: aminolevulinic acid Procedure: therapeutic conventional surgery |
Phase 2 |
Verified by
Michael Vogelbaum, MD, PhD
June, 2013
Sponsored by: Michael Vogelbaum, MD, PhD
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov identifier: NCT01575275
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States
Michael Vogelbaum, MD, PhD., Principal Investigator