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);
Parallel
5-aminolevulinic acid
DrugPatients were randomly assigned to 5-aminolevulinic acid (20 mg/kg bodyweight）Those randomly allocated to 5-aminolevulinic acid were scheduled to receive freshly prepared solutions of 5-aminolevulinic acid orally 3 h (range 2-4) before induction of anaesthesia. Solutions were prepared by dissolving the contents of a vial (1·5 g) in 50 mL of drinking water.
gross total resection rate(GTR rate）
Proportion of subjects in the test and control groups whose tumors were determined to have met the criteria for complete resection by cranial enhancement MRI within 72 hours postoperatively
Positive diagnostic rate of strongly fluorescent tissue biopsy specimens
Proportion of tissue specimens taken intraoperatively in the test group that were positive for tumor by pathological testing
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