Actively Recruiting
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-02-19
30
Participants Needed
1
Research Sites
536 weeks
Total Duration
On this page
Sponsors
F
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
U
University of Milan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Diagnosis of supratentorial glioblastoma at first occurrence (Grade 4, WHO 2021) confirmed by histology, in an area accessible for surgical removal
- Ability to give informed consent
- Suitable for surgery with fluorescence guidance using 5-ALA
- For other brain tumors: patient aged 18 years or older
- Ability to give informed consent
- Suitable for surgery with fluorescence guidance using 5-ALA
You will not qualify if you...
- Presence of other systemic tumors
- Known allergic sensitivity or contraindications to gadolinium
- Contraindications to MRI such as non-compatible implanted devices
- Significantly compromised kidney function (eGFR <30 ml/min/1.73 m²) or undergoing dialysis
- Conditions preventing surgery with 5-ALA fluorescence guidance
- For other brain tumors: systemic tumors besides primary brain metastasis
- Known allergies or adverse reactions to gadolinium
- MRI contraindications including incompatible implants
- Significantly reduced kidney function or dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
Research Team
F
Francesco Di Meco, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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