MedTrace Logo

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

NCT05850377 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2023-05-09

No results posted yet for this study

Summary

The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Conditions

  • High Grade Glioma
  • Glioma
  • Glioma, Malignant
  • Neoplasms, Neuroepithelial
  • Neuroectodermal Tumors
  • Photosensitizing Agents
  • Neoplasm Malignant
  • Brain Neoplasms, Adult, Malignant
  • Central Nervous System Neoplasms
  • Brain Tumor
  • Tumour, 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.

Sponsors & Collaborators

  • Sociedad de Lucha Contra el Cáncer del Ecuador

    lead OTHER

Principal Investigators

  • Alberto Valarezo Chuchuca, MD · Sociedad de Lucha Contra el Cáncer del Ecuador

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Ecuador

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05850377 on ClinicalTrials.gov