Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)

Phase 3 Recruiting 144 enrolled Lee's Pharmaceutical Limited

RandomizedParallel-groupOpen-labelDiagnostic

Summary

This is a randomized, open, parallel-group, multicenter clinical trial evaluating 5-aminolevulinic acid (5-ALA HCl) oral solution with powdered fluorescent microscopic tumor resection versus white light microscopic tumor resection in patients with malignant gliomas (WHO grade 3/4).

Timeline

Start: 2025-04-14
Primary completion: 2026-02
Completion: 2026-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aminolevulinic Acid	Diagnostic / imaging agent	20 mg/kg	Oral

Indications

No indication recorded.