5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in H… (NCT05850377) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
Ecuador90 participantsStarted 2023-06-01
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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 confir…
What they're measuring
1
Disease-Free-Survival (PFS)
Timeframe: 36 months
Trial details
NCT IDNCT05850377
SponsorSociedad de Lucha Contra el Cáncer del Ecuador