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

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.

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Key information

Conditions

5-aminolevulinic Acid Malignant Glioma of Brain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital, Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

5 Aminolevulinic Acid

Drug

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.

Primary outcomes

positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites

Time frame: within 48 hours after surgery

The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas.

Sponsors and collaborators

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 16, 2024
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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