Clinical trial · Interventional
Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）
A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
NCT06417281CI-TRIAL-00104835completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 5-aminolevulinic Acid | — | UNRESOLVED | — |
| Malignant Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 Aminolevulinic Acid | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5 Aminolevulinic Acid
- description
- This is an single arm study.
- interventionNames
- Drug: 5 Aminolevulinic Acid
Primary outcomes (1)
- measure
- positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
- timeFrame
- within 48 hours after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.