Phase 3 Study Comparing 5-Aminolevulinic Acid Fluorescence-Guided Microsurgery to Standard White Light Surgery for Malignant Gliomas WHO Grade 34

What this Trial Is About

Researchers are evaluating the effectiveness of 5-aminolevulinic acid hydrochloride 5-ALA HCl fluorescence-guided microsurgery compared to conventional white light microsurgery in patients with malignant gliomas WHO grade 34. This phase III, randomized, open, parallel-group, multicenter study aims to assess how well these two surgical methods remove tumor tissue safely. Participants are randomly assigned to either the test group or the control group in equal numbers. The test group receives an oral dose of 5-ALA HCl at 20 mgkg dissolved in drinking water 2 to 4 hours before anesthesia, followed by tumor removal guided by fluorescence microscopy. The control group undergoes traditional white light microscopic tumor resection. Both groups have cranial enhanced MRI scans within 72 hours after surgery to assess the extent of tumor removal. During the study, participants are monitored for adverse events starting 4 hours before the test drug administration or surgery and continuing through the postoperative safety follow-up. Researchers track the gross total resection rate within 72 hours after surgery as the primary outcome. They also evaluate the diagnostic rate of strongly fluorescent tissue biopsy specimens within 15 days post-surgery. Participants must comply with follow-up visits and assessments throughout the trial duration.

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)