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

This trial does not accept healthy volunteers

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 population

30 Patients with brain tumors whose treatment course involves fluorescence-guided surgery 5-ALA.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Glioblastoma Patients
Group B: Other Brain Tumor Patients

Trial outcomes

Primary outcomes

1

Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients

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.

Time frame
2 years

Secondary outcomes

1

PpIX Fluorescence Level in Control/Other Brain Tumor Patients

PpIX fluorescence level in blood (serum and plasma) and urine at different time-points in controls/patients with other brain tumor pathologies.

Time frame
2 years
2

Correlation of Fluorescence with Histopathological Characteristics

Correlation of PpIX fluorescence levels with histopathological characteristics of the tumor tissue.

Time frame
2 years
3

Correlation of Fluorescence with Tumor Tissue Fluorescence

Correlation of PpIX fluorescence levels in liquid biopsy (blood/urine) with the observed fluorescence of the tumor tissue during surgery

Time frame
2 years
4

Correlation of Fluorescence with MRI Lesion Volumes

Correlation of PpIX fluorescence levels with lesion volumes measured on pre-operative Magnetic Resonance Imaging (MRI).

Time frame
2 years

Other outcomes

Sponsors and contacts

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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