Trials / Not Yet Recruiting
Not Yet RecruitingNCT05850377
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (estimated)
- Sponsor
- Sociedad de Lucha Contra el Cáncer del Ecuador · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 5-Aminolevulinic Acid (5-ALA) Gliolan® | 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. |
| PROCEDURE | Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA) | 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. |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
- First posted
- 2023-05-09
- Last updated
- 2023-05-09
Locations
1 site across 1 country: Ecuador
Source: ClinicalTrials.gov record NCT05850377. Inclusion in this directory is not an endorsement.