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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

30 Participants
are grouped into 2 trial groups

Sponsors and collaborators

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

Lead sponsor

University of Milan

Collaborator

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Collaborator