Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)

PHASE3RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

April 14, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
5-aminolevulinic AcidFluorescence-guided Resection
Interventions
DRUG

5-aminolevulinic acid

Patients were randomly assigned to 5-aminolevulinic acid (20 mg/kg bodyweight)Those randomly allocated to 5-aminolevulinic acid were scheduled to receive freshly prepared solutions of 5-aminolevulinic acid orally 3 h (range 2-4) before induction of anaesthesia. Solutions were prepared by dissolving the contents of a vial (1·5 g) in 50 mL of drinking water.

Trial Locations (2)

510000

NOT_YET_RECRUITING

Sun Yat-Sen University Cancer Center, Guangzhou

Unknown

RECRUITING

Henan Province Tumor Hospital, Zhengzhou

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY