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
This trial does not accept healthy volunteersQualifiers
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 population
30 Patients with brain tumors whose treatment course involves fluorescence-guided surgery 5-ALA.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
PpIX fluorescence level in blood (serum and plasma) and urine at different time-points (pre-administration, 12h post-administration, and potentially other timepoints depending on preliminary observations) in patients with glioblastoma.
Secondary outcomes
PpIX Fluorescence Level in Control/Other Brain Tumor Patients
PpIX fluorescence level in blood (serum and plasma) and urine at different time-points in controls/patients with other brain tumor pathologies.
Correlation of Fluorescence with Histopathological Characteristics
Correlation of PpIX fluorescence levels with histopathological characteristics of the tumor tissue.
Correlation of Fluorescence with Tumor Tissue Fluorescence
Correlation of PpIX fluorescence levels in liquid biopsy (blood/urine) with the observed fluorescence of the tumor tissue during surgery
Correlation of Fluorescence with MRI Lesion Volumes
Correlation of PpIX fluorescence levels with lesion volumes measured on pre-operative Magnetic Resonance Imaging (MRI).
Sponsors and contacts
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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