drugset / Trial / NCT01116661

Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain

NCT01116661

Phase 2 Terminated 199 enrolled University of California, San Francisco
NaSingle-groupOpen-labelTreatment

Summary

The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.

Timeline

Start
2010-08
Primary completion
2017-12-28
Completion
2019-02-28

Drugs

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

Indications