Clinical trial NCT05850377: 5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
Official title: 5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Sociedad de Lucha Contra el Cáncer del Ecuador
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

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

Primary outcomes:
measure: Disease-Free-Survival (PFS)
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 36 months
measure: Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire
timeFrame: 36 months
measure: Average length of hospital stay (ALOS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Sociedad de Lucha Contra el Cáncer
state: Guayas
Study officials:
affiliation: Sociedad de Lucha Contra el Cáncer del Ecuador
name: Alberto Valarezo Chuchuca, MD
role: PRINCIPAL_INVESTIGATOR
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