Using 5-ALA for better diagnosis and treatment of malignant brain glioma
A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
This study is testing if a single dose of a special drug can help doctors better see and remove brain tumors in adults with aggressive brain cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06417281 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial evaluates the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) in patients with newly diagnosed or recurrent malignant high-grade glioma. The study is open-label and multicenter, focusing on fluorescence-guided tumor resection and photodynamic diagnosis. Participants will undergo surgical tumor resection based on radiological suspicion of malignant glioma, with the aim of improving surgical outcomes. The trial includes patients aged 18-75 with a Karnofsky Performance Status of 70 or higher.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of malignant glioma and an indication for surgical resection.
Not a fit: Patients with tumors located in critical brain areas such as the basal ganglia, thalamus, cerebellum, or brainstem may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of tumor resection and improve patient outcomes in malignant glioma treatment.
How similar studies have performed: Previous studies have shown promising results with the use of 5-ALA in glioma surgeries, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Shanghai
- Huashan Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: jingsong wu, doctor
- Email: wujinsong@huashan.org.cn
- Phone: +8613701707118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.