NCT07286903

Fluorescence Enhanced Stereotactic Surgery (FESS)

Fluorescence Enhanced Stereotactic Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

'The study focuses on the "Fluorescence Enhanced Stereotactic Surgery" (FESS) project. It is a prospective, multicenter, observational study on a device. The study consists of three phases: Phase 1: Development and prototyping of fiber optic probes (by partner CERICT), integration into a standard biopsy needle, and software development. Phase 2: In vitro testing on phantoms and ex-vivo testing on biological tissue. Ex-vivo tests will be performed on intra-axial brain tumor samples resected during standard surgery (guided by 5-ALA fluorescence). The probe will be inserted into the resected sample to detect fluorescence and vascular signals. Results will be correlated with histopathological analysis. Phase 3: Optimization and final validation of the integrated system. Approximately 20 samples of high-grade glioma will be analyzed. The goal is to verify if the probe can distinguish tumor tissue (via 5-ALA fluorescence) and identify blood vessels (via ultrasound/Raman) to prevent hemorrhage during biopsies.

Conditions

• High Grade Glioma
• High Grade Glioma (III or IV)

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: Italy