Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Tumors and/or Solid Tumors Including, Glioblastoma, Glioblastoma (GBM), Glioblastoma - Category. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Primary outcome measures
- Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients [Time frame: 2 years]
Secondary outcome measures (5)
- PpIX Fluorescence Level in Control/Other Brain Tumor Patients [Time frame: 2 years]
- Correlation of Fluorescence with Histopathological Characteristics [Time frame: 2 years]
- Correlation of Fluorescence with Tumor Tissue Fluorescence [Time frame: 2 years]
- Correlation of Fluorescence with MRI Lesion Volumes [Time frame: 2 years]
- Kinetics of 5-ALA-induced Fluorescence [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
Identifiers
NCT: NCT07420543 · FLUO-LB