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Trial Title:
Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）
NCT ID:
NCT06417281
Condition:
5-aminolevulinic Acid
Malignant Glioma of Brain
Conditions: Official terms:
Glioma
Aminolevulinic Acid
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
5 Aminolevulinic Acid
Description:
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.
Arm group label:
5 Aminolevulinic Acid
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.
Criteria for eligibility:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Huashan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
jingsong wu, Doctor
Start date:
June 19, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06417281
