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

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

NCT ID: NCT05850377

Condition: 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

Conditions: Official terms:
Neoplasms
Glioma
Brain Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neoplasm, Residual
Dermatitis, Phototoxic
Aminolevulinic Acid

Conditions: Keywords:
High Grade Glioma
5-ALA
Aminolevulinic Acid
Malignant Glioma
Photodynamic Therapy
Fluorescence-guided Surgery
Photosensitizing Agents
Tumor Resection

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: 5-Aminolevulinic Acid (5-ALA) Gliolan®
Description: 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.
Arm group label: Participants with known or suspected High-Grade Gliomas

Other name: Gliolan®

Other name: Gleolan®

Intervention type: Procedure
Intervention name: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
Description: 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.
Arm group label: Participants with known or suspected High-Grade Gliomas

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

Detailed 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.

Criteria for eligibility:

Study pop:
High-Grade Gliomas patients according to the 2021 World Health Organization (WHO) classification at Instituto Oncológico Nacional Dr. Juan Tanca Marengo

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sociedad de Lucha Contra el Cáncer

Address:
City: Guayaquil
Country: Ecuador

Contact:
Last name: Alberto Valarezo Chuchuca, MD

Phone: +593 998 686 027
Email: valarezoalb@hotmail.com

Investigator:
Last name: Alberto Valarezo Chuchuca, MD
Email: Principal Investigator

Start date: June 1, 2023

Completion date: May 31, 2026

Lead sponsor:
Agency: Sociedad de Lucha Contra el Cáncer del Ecuador
Agency class: Other

Source: Sociedad de Lucha Contra el Cáncer del Ecuador

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05850377