Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
NCT07420543
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.
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.
Conditions5
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT07420543