A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
5 Aminolevulinic Acid
This is an single arm study.
Intervention: 5 Aminolevulinic Acid (Drug)
Outcomes
Primary Outcomes
positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
Time Frame: 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 Outcomes
No secondary outcomes reported