RecruitingNCT07420543

Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Enrollment

30 participants

Start Date

Jan 18, 2017

Study Type

OBSERVATIONAL

Conditions

Glioblastoma Glioblastoma (GBM)Glioblastoma - Category Brain Tumors and/or Solid Tumors Including

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

Min Age: 18 Years

Inclusion Criteria7

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.
Patient aged 18 years or older
Ability of the patient to give informed consent.
Suitability for surgery with fluorescence guidance using 5-ALA.

Exclusion Criteria9

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.
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.