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

Malignant Glioma of Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417281
• Other study ID #: F0009-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: jingsong wu, doctor
• Phone: +8613701707118
• Email: wujinsong[@]huashan.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma of Brain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites	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.	within 48h after surgery