Overview
This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.
Eligibility
Inclusion Criteria:
- Patient's written informed consent
- Age 18-75 years
- Radiological suspicion of a malignant glioma
- Indication for surgical tumour resection
- Karnofsky Performance Status (KPS) ≥ 70
Exclusion Criteria:
- Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
- Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
- known hypersensitivity to the test drug ingredients
- Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;