Clinical Trial

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)

Recruiting Phase 3
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Record status
This record was last updated May 13, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-12-06; most recent amendment 2025-05-09.
Status change: Not Yet Recruiting → Recruiting 2025-05-09
Trial Details
NCT Number NCT06160492
Lead Sponsor Lee's Pharmaceutical Limited
Conditions 5-aminolevulinic Acid, Fluorescence-guided Resection
Enrollment 144 participants
Start Date 2025-04-14
Primary Completion 2026-02 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-05-13