NCT01575275

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Michael Vogelbaum, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	aminolevulinic acid	Given PO
PROCEDURE	therapeutic conventional surgery	Undergo surgery

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2012-04-11
• Last updated: 2018-07-31
• Results posted: 2018-07-31

Locations

1 site across 1 country: United States