drugset / Trial / NCT00671710

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

NCT00671710

Phase 1 Completed 26 enrolled Advocate Hospital System
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2008-04
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 10 mg/kg Oral
Subject Aminolevulinic Acid Diagnostic / imaging agent 20 mg/kg Oral
Subject Aminolevulinic Acid Diagnostic / imaging agent 30 mg/kg Oral

Indications