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.
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.
Study Type
OBSERVATIONAL
Enrollment
30
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
RECRUITINGProtoporphyrin 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.
Time frame: 2 years
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.
Time frame: 2 years
Correlation of Fluorescence with Histopathological Characteristics
Correlation of PpIX fluorescence levels with histopathological characteristics of the tumor tissue.
Time frame: 2 years
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
Time frame: 2 years
Correlation of Fluorescence with MRI Lesion Volumes
Correlation of PpIX fluorescence levels with lesion volumes measured on pre-operative Magnetic Resonance Imaging (MRI).
Time frame: 2 years
Kinetics of 5-ALA-induced Fluorescence
Describe the kinetics (changes over time) of 5-ALA-induced fluorescence in plasma and urine levels.
Time frame: 2 years
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