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Clinical Trials in Italy / NCT07286903
Recruiting Observational

Fluorescence Enhanced Stereotactic Surgery (FESS)

NCT07286903 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-07-01
Last updated
2025-12-16

Condition(s) studied

High Grade GliomaHigh Grade Glioma (III or IV)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged 18 years or older * Patients able to provide the informed consentPresumptive diagnosis of high grade glioma * Patient whose surgery require the use of 5-ALA as standard of treatment Exclusion Criteria: * Patients who are not suitable for surgery * Patients unable to provide informed consent due to cognitive impairment or other reasons

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286903 on ClinicalTrials.gov ↗ ← All trials in Italy