Brain Tumors and/or Solid Tumors Including, Glioblastoma, Glioblastoma - Category, Glioblastoma (GBM)
Conditions
Keywords
Glioblastoma (GBM), Glioblastoma, Liquid Biopsy, GBM, 5-ALA, Protoporphyrin IX (PpIX), Fluorescence
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
University of Milan
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients | 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| PpIX Fluorescence Level in Control/Other Brain Tumor Patients | 2 years | 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 | 2 years | Correlation of PpIX fluorescence levels with histopathological characteristics of the tumor tissue. |
| Correlation of Fluorescence with Tumor Tissue Fluorescence | 2 years | 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 | 2 years | Correlation of PpIX fluorescence levels with lesion volumes measured on pre-operative Magnetic Resonance Imaging (MRI). |
| Kinetics of 5-ALA-induced Fluorescence | 2 years | Describe the kinetics (changes over time) of 5-ALA-induced fluorescence in plasma and urine levels. |
Countries
Italy
Outcome results
None listed