An observational study in High Grade Glioma, Glioma and Glioma, Malignant, sponsored by Sociedad de Lucha Contra el Cáncer del Ecuador. Not yet recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Sociedad de Lucha Contra el Cáncer del Ecuador · Observational
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
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.
High-Grade Gliomas patients according to the 2021 World Health Organization (WHO) classification at Instituto Oncológico Nacional Dr. Juan Tanca Marengo
Exclusion Criteria:
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)
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®
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.
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)
Time frame: 36 months
Overall survival (OS)
Overall survival is defined as time from initiation to death of any cause
Time frame: 36 months
Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire
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.
Time frame: 36 months
Average length of hospital stay (ALOS)
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.
Time frame: 36 months
Plan to share: No
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sociedad de Lucha Contra el Cáncer del Ecuador