Clinical trial

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

Name

CISOLGYE20230023

Description

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

Trial arms

Trial start

2023-06-01

Estimated PCD

2026-05-31

Trial end

2026-05-31

Status

Not yet recruiting

Treatment

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.

Arms:

Participants with known or suspected High-Grade Gliomas

Other names:

Gliolan®, Gleolan®

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.

Arms:

Participants with known or suspected High-Grade Gliomas

Size

Primary endpoint

Disease-Free-Survival (PFS)

36 months

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor samples'}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-05-09

1 organization

1 product

14 indications

Organization

Sociedad de Lucha Contra el Cáncer del Ecuador

Product

5-Aminolevulinic Acid

Indication

High-Grade Glioma

Indication