Clinical Trial

Fluorescence Enhanced Stereotactic Surgery (FESS)

Study acronym: FESS
Recruiting
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Record status
This record was last updated December 16, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07286903
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators: Federico II University
Conditions High Grade Glioma, High Grade Glioma (III or IV)
Enrollment 20 participants
Start Date 2024-07-01
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-16