5-aminolevulinic Acid, Malignant Glioma of Brain
Conditions
Brief summary
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.
Interventions
3±1 hours before anesthesia, participants will take 5-ALA orally at a dosage of 20 mg/kg, followed by fluorescence-guided resection of malignant glioma.
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites | within 48 hours after surgery | The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas. |
Countries
China
Outcome results
None listed