A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid

Trial ID: NCT06417281

Interventional - Phase 3 - Completed

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.

Conditions

• 5-aminolevulinic Acid
• Malignant Glioma of Brain

Interventions

• 5 Aminolevulinic Acid

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;

Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Source: ClinicalTrials.gov

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