drugset / Trial / NCT00241670

Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

NCT00241670 ↗

Phase 3 Completed 415 enrolled medac GmbH
RandomizedParallel-groupSingle-blindDiagnostic

Summary

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Timeline

Start
1999-10
Primary completion
2004-07
Completion
—

Outcome

Met primary endpoint

paper 5-aminolevulinic acid compared with 47 (36%) of 131 assigned white light (difference between groups 29% [95% CI 17-40], p<0.0001). PMID 16648043 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 1.5 g Oral