Overview
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.
Description
This is a prospective observational study. Patients with suspected brain tumors requiring 5-ALA fluorescence-guided surgery will be enrolled. Samples of plasma, serum, and urine will be collected at a minimum of two timepoints: once before 5-ALA administration (baseline, T1) and again 12 hours after administration (T2), when PpIX levels are expected to be highest. All sample collection and processing will occur in low-light conditions to prevent PpIX degradation. Samples will be stored at -80°C. Fluorometric analysis (Perkin Elmer Wallac 1420 Victor2 Microplate Reader) will be performed to measure PpIX fluorescence. Additionally, each patient will undergo a pre-operative MRI as per routine care to measure tumor volume, which will be correlated with fluorescence data.
Eligibility
Inclusion Criteria:
- Inclusion Criteria (Glioblastoma Patients):
- 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.
Inclusion Criteria (Other Brain Tumors):
- Patient aged 18 years or older
- Ability of the patient to give informed consent.
- Suitability for surgery with fluorescence guidance using 5-ALA.
Exclusion Criteria:
Exclusion Criteria (Glioblastoma Patients):
- 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.
- Conditions that contraindicate surgery with fluorescence guidance using 5-ALA.
Exclusion Criteria (Other Brain Tumors):
- Patients suffering from systemic tumors (besides the primary of the brain metastasis).
- Individuals with known allergies or adverse reactions to gadolinium.
- Individuals with contraindications for MRI, including those with implants not compatible with the procedure.
- Individuals with significantly reduced kidney function (eGFR \< 30 ml/min/1.73 m²), or those undergoing dialysis.
