A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
jingsong wu, doctor
wujinsong@huashan.org.cn
+8613701707118
Time Frame
Start Date: 2024-06-19
Estimated Completion Date: 2025-08
Participants
Target number of participants: 80
Treatments
Experimental: 5 Aminolevulinic Acid
This is an single arm study.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.