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

Launched by SOCIEDAD DE LUCHA CONTRA EL CÁNCER DEL ECUADOR · Apr 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called 5-aminolevulinic acid (5-ALA) to help improve outcomes for patients with high-grade gliomas, which are serious types of brain tumors. The study aims to see if using this treatment during surgery can help patients live longer without their cancer coming back. It is important to note that the trial is not currently recruiting participants.

To be eligible for this study, patients need to be between 18 and 75 years old and have a high-grade glioma that has been confirmed through imaging tests. This includes patients who have had surgery but still have some tumor left or those whose tumors have come back after previous treatments. However, certain conditions, such as having specific types of brain tumors or serious health issues, may prevent someone from participating. If eligible, participants can expect to undergo surgery where 5-ALA will be used to help doctors see the tumor more clearly, which may improve treatment outcomes.

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ALL

Eligibility criteria

• 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