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).
Males or females 18-70 years of age, inclusive;
Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging;
have a Karnofsky Performance Status (KPS) ≥ 60;
Ability to take oral medications;
Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs;
acute or chronic porphyria; history of cutaneous photosensitivity, actinic dermatoses, and exfoliative dermatitis
Tumor located in the midline, basal ganglia, cerebellum, or brainstem;
Inability to undergo enhanced MRI (pacemaker, contrast allergy, and other reasons);