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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05850377
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sociedad de Lucha Contra el Cáncer del Ecuador
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alberto Valarezo Chuchuca, MD
Principal Investigator Affiliation	Sociedad de Lucha Contra el Cáncer del Ecuador
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Ecuador
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Arms & Interventions

Arms

: Participants with known or suspected High-Grade Gliomas

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

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.

Contact a Trial Team

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