drugset / Trial / NCT02755142

Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

NCT02755142

Phase 1/2 Completed 21 enrolled medac GmbH IKP · collab
RandomizedParallel-groupDouble-blind

Summary

This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.

Timeline

Start
2000-02
Primary completion
2001-06
Completion
2001-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aminolevulinic Acid Diagnostic / imaging agent 0.2 mg/kg
Comparator Aminolevulinic Acid Diagnostic / imaging agent 2 mg/kg
Comparator Aminolevulinic Acid Diagnostic / imaging agent 20 mg/kg

Indications