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

NCT07420543 | Recruiting

• 1 other identifier: FLUO-LB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Glioblastoma (GBM); Glioblastoma; Liquid Biopsy; GBM; 5-ALA; Protoporphyrin IX (PpIX); Fluorescence

Outcome Measures

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.

  2 years

Secondary Outcomes (5)

• PpIX Fluorescence Level in Control/Other Brain Tumor Patients

  2 years

• Correlation of Fluorescence with Histopathological Characteristics

  2 years

• Correlation of Fluorescence with Tumor Tissue Fluorescence

  2 years

• Correlation of Fluorescence with MRI Lesion Volumes

  2 years

• Kinetics of 5-ALA-induced Fluorescence

  2 years

Study Arms (2)

Glioblastoma Patients

Patients aged 18 or older with a first diagnosis of supratentorial glioblastoma (WHO Grade 4), confirmed by histology, who are candidates for 5-ALA fluorescence-guided surgery.

Other Brain Tumor Patients

Patients aged 18 or older with other brain tumors (in differential diagnosis with glioblastoma) who are candidates for 5-ALA fluorescence-guided surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• University of Milan: collaborator
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Francesco Di Meco, MD

CONTACT

+ 39 02.2394; francesco.dimeco@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 19, 2026
• Study Start: January 18, 2017
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)