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

NCT06417281 | Completed Phase 3

• 1 other identifier: F0009-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 48 hours after surgery

Study Arms (1)

5 Aminolevulinic Acid

EXPERIMENTAL

This is an single arm study.

Drug: 5 Aminolevulinic Acid

Interventions

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.

5 Aminolevulinic Acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

Aminolevulinic Acid

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: June 19, 2024
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CN (1)