Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）
Phase 3
Recruiting
- Conditions
- 5-aminolevulinic AcidMalignant Glioma of Brain
- Interventions
- Drug: 5 Aminolevulinic Acid
- Registration Number
- NCT06417281
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5 Aminolevulinic Acid 5 Aminolevulinic Acid This is an single arm study.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Huashan Hospital, Fudan University
🇨🇳Shanghai, China