About this trial
Glioblastoma (GBM) is the most common and lethal primary brain tumor. Identifying blood biomarkers that reflect the tumor's status is a major unmet need for optimal clinical management. 5-ALA (5-Aminolevulinic Acid) administration leads to the accumulation of fluorescent Protoporphyrin IX (PpIX) in GBM cells, allowing identification during surgery. This project aims to leverage 5-ALA induced fluorescence to maximize the informational power of plasma liquid biopsy as a tool for diagnosis, post-treatment follow-up, and as a prognostic tool in patients with GBM.
Eligibility criteria
Qualifiers
Patient aged 18 years or older
Diagnosis of supratentorial glioblastoma at its first occurrence (Grade 4, WHO 2021), confirmed through histological analysis, in a brain area that is accessible for surgical removal.
Ability of the patient to give informed consent.
Suitability for surgery with fluorescence guidance using 5-ALA.
Disqualifiers
Presence of other systemic tumors.
Known allergic sensitivity or contraindications to gadolinium.
Contraindications to MRI, such as the presence of non-compatible implanted devices.
Significantly compromised renal function (eGFR <30 ml/min/1.73 m²), and/or patients undergoing dialysis.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
University of Milan
Collaborator
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborator