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

NCT ID: NCT06417281

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2025-08-31

Brief 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.

Conditions

5-aminolevulinic Acid; Malignant Glioma of Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

5 Aminolevulinic Acid

This is an single arm study.

Group Type: EXPERIMENTAL

5 Aminolevulinic Acid

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

jingsong wu, doctor

Role: CONTACT

wujinsong@huashan.org.cn

+8613701707118

Facility Contacts

jingsong wu, Doctor

Role: primary

Other Identifiers

F0009-01

Identifier Type: -

Identifier Source: org_study_id