Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Malignant Glioma of Brain; 5-aminolevulinic Acid

Treatments: Drug: 5 Aminolevulinic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06417281

F0009-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

5 Aminolevulinic Acid

Experimental group

Description:

This is an single arm study.

Treatment:

Drug: 5 Aminolevulinic Acid