Actively Recruiting
Fluorescence Enhanced Stereotactic Surgery (FESS)
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2025-12-16
20
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
F
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
F
Federico II University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Histopathological diagnosis is essential for gliomas, but stereotactic biopsy carries significant risks and can fail to provide diagnostic tissue. This study aims to develop and validate an advanced fiber optic system integrated into a standard Nashold biopsy needle. This system combines 5-ALA fluorescence, Raman spectroscopy, and ultrasound imaging to provide real-time feedback on tumor tissue and blood vessels. The study involves ex-vivo testing on brain tumor tissues (High Grade Glioma) obtained through surgical resection to validate the system's ability to identify tumor margins and vascular structures, aiming to improve biopsy safety and accuracy.
CONDITIONS
Official Title
Fluorescence Enhanced Stereotactic Surgery (FESS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Patients able to provide informed consent
- Presumptive diagnosis of high grade glioma
- Patient whose surgery requires the use of 5-ALA as standard treatment
You will not qualify if you...
- Patients who are not suitable for surgery
- Patients unable to provide informed consent due to cognitive impairment or other reasons
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
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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