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

Sociedad de Lucha Contra el Cáncer del Ecuador

Status: Not yet enrolling

Conditions: Photosensitizing Agents; Glioma; Brain Tumor; Neuroectodermal Tumors; High Grade Glioma; Neoplasm Malignant; Glioma, Malignant; Brain Neoplasms, Adult, Malignant; Tumour, Residual; Neoplasms, Neuroepithelial; Central Nervous System Neoplasms

Treatments: Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA); Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®

Study type: Observational

Funder types: Other

Identifiers

NCT05850377

CISOLGYE20230023

Details and patient eligibility

About

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

Full description

The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
• Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
• Patients with high-grade and residual glioma following surgery for gross total resection
• Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
• Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
• Progressing, low-grade infiltrative gliomas with one of the following criteria:
• Anaplastic foci with contrast uptake in MRI
• Spectroscopy study in anaplastic suspected area with high malignancy criteria
• Positive choline PET-CT (positron emission tomography / computer tomography)

Exclusion criteria

• Tumors extending across midline
• Basal ganglia tumor
• Brainstem tumor
• Multifocal gliomas
• Suspected low-grade glioma without anaplastic foci
• Neuraxial dissemination (ependymoma)
• Karnofsky grade less than 60%
• Infants or pregnant women
• Acute or chronic types of porphyria
• Non-acceptance of Fluorescence-Guided Surgery
• Renal insufficiency confirmed by nephrological assessment
• Hepatic impairment confirmed by gastroenterological assessment
• Severe heart disease confirmed by cardiological assessment
• Decompensated diabetes confirmed by endocrinological assessment
• Known allergy to any contrast agent and/or previous history of anaphylactic shock
• Hypersensitivity to the active substance or porphyrins
• Asthma confirmed by pulmonological assessment
• Pacemaker use

Trial design

90 participants in 1 patient group

Participants with known or suspected High-Grade Gliomas

Description:

Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Treatment:

Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®

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