Status: Recruiting
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)
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).
Participants needed: 144
Trial details
Phase: Phase 3Age: 18-70Biological sex: AllType: InterventionalSponsor: Lee's Pharmaceutical LimitedUpdated: May 13, 2025Locations: 2
Eligibility criteria
Males or females 18-70 years of age, inclusive; [+5]
Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyr... [+7]