5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

Not yet recruitingOBSERVATIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
High Grade GliomaGliomaGlioma, MalignantNeoplasms, NeuroepithelialNeuroectodermal TumorsPhotosensitizing AgentsNeoplasm MalignantBrain Neoplasms, Adult, MalignantCentral Nervous System NeoplasmsBrain TumorTumour, Residual
Interventions
DRUG

5-Aminolevulinic Acid (5-ALA) Gliolan®

Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

PROCEDURE

Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.

Trial Locations (1)

Unknown

Sociedad de Lucha Contra el Cáncer, Guayaquil

All Listed Sponsors
lead

Sociedad de Lucha Contra el Cáncer del Ecuador

OTHER

NCT05850377 - 5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas | Biotech Hunter | Biotech Hunter