NCT00671710

Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Advocate Hospital System · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. However, the infiltrative nature of the malignant cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts toward total resection. The investigators propose to identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the malignant cells and thereby provide more complete tumor resection.

Conditions

• Brain Tumors

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid	Escalating doses (10mg/kg, 20mg/kg, 30mg/kg) of Aminolevulinic Acid administered orally 3 hours prior to surgery to enhance visualization of malignant brain tumor.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-05-05
• Last updated: 2011-01-14

Locations

1 site across 1 country: United States