Trials / Completed
CompletedNCT06417281
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 5 Aminolevulinic Acid | 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. |
Timeline
- Start date
- 2024-06-19
- Primary completion
- 2025-08-19
- Completion
- 2025-08-19
- First posted
- 2024-05-16
- Last updated
- 2026-03-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06417281. Inclusion in this directory is not an endorsement.