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Fluorescence Enhanced Stereotactic Surgery (FESS)

NCT07286903 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-12-16

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Principal Investigators

  • Elisa Ciceri · Fondazione IRCCS Istituto Neurologico Carlo Besta

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286903 on ClinicalTrials.gov