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RECRUITING
NCT06160492
PHASE3

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)

Sponsor: Lee's Pharmaceutical Limited

View on ClinicalTrials.gov

Summary

This is a randomized, open, parallel-group, multicenter clinical trial evaluating 5-aminolevulinic acid (5-ALA HCl) oral solution with powdered fluorescent microscopic tumor resection versus white light microscopic tumor resection in patients with malignant gliomas (WHO grade 3/4).

Official title: Phase III Clinical Trial Evaluating the Efficacy of 5-aminolevulinic Acid (5-ALA HCl) Fluorescence-guided Microsurgery Versus Conventional White Light Microsurgical Resection in Patients With Malignant Gliomas (WHO Grade 3/4)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-04-14

Completion Date

2026-03

Last Updated

2025-05-13

Healthy Volunteers

No

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.

Locations (2)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Henan Province Tumor Hospital

Zhengzhou, Henan, China