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
52 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 deadly primary brain tumor. Researchers are studying how blood biomarkers related to the tumor can help with diagnosis, monitoring after treatment, and predicting outcomes. The study focuses on using 5-ALA (5-Aminolevulinic Acid) which causes fluorescent Protoporphyrin IX (PpIX) to build up in GBM cells, making them visible during surgery. This observational study aims to use this fluorescence to improve plasma liquid biopsy methods for brain tumor patients. Patients with suspected brain tumors who need 5-ALA fluorescence-guided surgery will be enrolled. Blood plasma, serum, and urine samples will be collected twice: before 5-ALA is given and 12 hours after, when PpIX is expected to peak. Samples will be carefully handled in low light and stored frozen. Fluorescence levels will be measured using special equipment. Each patient will also have a pre-operative MRI to measure tumor size, which will be compared to fluorescence data. Participants will provide biological samples at two key times around surgery and have routine MRI scans. Researchers will analyze PpIX fluorescence levels and how they relate to tumor tissue and MRI findings over two years. The study will monitor fluorescence patterns and compare results between glioblastoma patients and those with other brain tumors. This helps understand how well fluorescence-guided liquid biopsy can aid in clinical care of brain tumor patients.
CONDITIONS
Brief 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, accessible for surgical removal
- Ability to provide informed consent
- Suitable for surgery with fluorescence guidance using 5-ALA
- For other brain tumors: patient aged 18 years or older
- Ability to provide informed consent
- Suitable for surgery with fluorescence guidance using 5-ALA
You will not qualify if you...
- Presence of other systemic tumors (for glioblastoma patients)
- Known allergy or contraindication to gadolinium
- Contraindications to MRI, including incompatible implanted devices
- Significantly compromised kidney function (eGFR <30 ml/min/1.73 m²) or dialysis
- Conditions preventing surgery with 5-ALA fluorescence guidance
- For other brain tumors: systemic tumors besides primary brain metastasis
- Allergy or adverse reaction 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo a pre-operative MRI as part of routine care to measure tumor volume.
1 visit (in-person)
Duration - Within 12 hours
Samples of plasma, serum, and urine are collected before and after 5-ALA administration under low-light conditions to measure PpIX fluorescence.
2 visits (in-person): one at baseline before 5-ALA administration and one approximately 12 hours after
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
Research Team
F
Francesco Di Meco, MD
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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