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

NCT05850377 | Not Yet Recruiting

• 1 other identifier: CISOLGYE20230023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-Free-Survival (PFS)

  Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

  36 months

Secondary Outcomes (3)

• Overall survival (OS)

  36 months

• Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire

  36 months

• Average length of hospital stay (ALOS)

  36 months

Study Arms (1)

Participants with known or suspected High-Grade Gliomas

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

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

Interventions

5-Aminolevulinic Acid (5-ALA) Gliolan® DRUG

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.

Also known as: Gliolan®, Gleolan®

Participants with known or suspected High-Grade Gliomas

Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA) PROCEDURE

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.

Participants with known or suspected High-Grade Gliomas

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad de Lucha Contra el Cáncer del Ecuador: lead

Study Sites (1)

Sociedad de Lucha Contra el Cáncer

Guayaquil, Guayas, Ecuador

Location

Related Publications (25)

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• Wainwright JV, Endo T, Cooper JB, Tominaga T, Schmidt MH. The role of 5-aminolevulinic acid in spinal tumor surgery: a review. J Neurooncol. 2019 Feb;141(3):575-584. doi: 10.1007/s11060-018-03080-0. Epub 2018 Dec 29.

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• Esteves S, Alves M, Castel-Branco M, Stummer W. A pilot cost-effectiveness analysis of treatments in newly diagnosed high-grade gliomas: the example of 5-aminolevulinic Acid compared with white-light surgery. Neurosurgery. 2015 May;76(5):552-62; discussion 562. doi: 10.1227/NEU.0000000000000673.

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• Kaneko S, Kaneko S. Fluorescence-Guided Resection of Malignant Glioma with 5-ALA. Int J Biomed Imaging. 2016;2016:6135293. doi: 10.1155/2016/6135293. Epub 2016 Jun 27.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor samples

MeSH Terms

Conditions

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Neoplasm, Residual

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Alberto Valarezo Chuchuca, MD

  Sociedad de Lucha Contra el Cáncer del Ecuador

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Valarezo Chuchuca, MD

CONTACT

+593 998 686 027; valarezoalb@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)