Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid

ID
Name
F0009-01
Description
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.
Trial arms
Trial start
2024-06-01
Estimated PCD
2025-08-01
Trial end
2025-08-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
5 Aminolevulinic Acid
Size
80
Primary endpoint
positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
within 48h after surgery
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-05-17

1 organization

1 product

2 indications

Organization
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical
Product
5 Aminolevulinic Acid
Indication
5-Aminolevulinic acid
Indication
Malignant Glioma of Brain