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

Not yet recruiting

• Conditions: Neoplasm Malignant; High Grade Glioma; Glioma; Neuroectodermal Tumors; Neoplasms, Neuroepithelial; Glioma, Malignant; Photosensitizing Agents; Central Nervous System Neoplasms; Brain Neoplasms, Adult, Malignant; Brain Tumor
• Interventions: Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®; Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

• Registration Number: NCT05850377
• Lead Sponsor: Sociedad de Lucha Contra el Cáncer del Ecuador

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Study Start: 2023-06-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with known or suspected High-Grade Gliomas	5-Aminolevulinic Acid (5-ALA) Gliolan®	Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
Participants with known or suspected High-Grade Gliomas	Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)	Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Primary Outcome Measures

Name	Time	Method
Disease-Free-Survival (PFS)	36 months	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)

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	36 months	Overall survival is defined as time from initiation to death of any cause
Average length of hospital stay (ALOS)	36 months	The average length of stay in hospitals is often used as an indicator of efficiency. The ALOS refers to the average number of days that patients spend in hospital after surgery. It is calculated by dividing the number of bed-days by the number of discharges after procedure. Average length of stay range from 1 day to 4.5 days. Longer than average stays are usually a symptom of poor communication, quality of care, and effectiveness of treatment.
Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire	36 months	The questionnaire provides an additional set of disease-specific questions pertaining to brain neoplasms. It consists of 46 items that refer to general issues of quality of life and specific to tumor location. Possible scores range from 0 to 108, with higher scores indicating better quality of life.

Trial Locations

Locations (1)

Sociedad de Lucha Contra el Cáncer; 🇪🇨 Guayaquil, Guayas, Ecuador