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RECRUITING
NCT06160492
PHASE3

5-Aminolevulinic Acid for Photodynamic Diagnosis of Malignant Glioma

Sponsor: Lee's Pharmaceutical Limited

View on ClinicalTrials.gov

Summary

This phase III, multicenter, open-label, single-arm study will evaluate the ability of 5-aminolevulinic acid hydrochloride (5-ALA HCl) powder for oral solution to visualize malignant tissue during surgery, and its safety, in adults with suspected or confirmed malignant high-grade glioma (WHO grade 3 or 4). Participants will receive oral 5-ALA HCl before surgery. The primary assessments will determine the proportion of biopsy specimens containing tumor cells in strongly and weakly fluorescent regions, evaluated separately using central histopathology. Secondary assessments will include postoperative residual tumor on MRI, participant-level positive predictive values, histopathological findings in nonfluorescent regions, and safety.

Official title: A Phase III Clinical Study of 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution for Photodynamic Diagnosis of Malignant Glioma (WHO Grade 3 or 4)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

79

Start Date

2025-04-14

Completion Date

2027-12

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution

One 1.5-g vial will be reconstituted in 50 mL of drinking water to give a 30-mg/mL solution. The protocol specifies 20 mg/kg; the administered volume will be selected from the protocol body-weight-based dosing table, up to a maximum of one vial (1.5 g). The solution will be administered orally 3 hours before anesthesia (range, 2 to 4 hours) on the day of surgery.

Locations (2)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Henan Province Tumor Hospital

Zhengzhou, Henan, China