Fluorescence Enhanced Stereotactic Surgery (FESS) (FESS)

Fluorescence Enhanced Stereotactic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: High Grade Glioma; High Grade Glioma (III or IV)

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Contact: Elisa Ciceri, MD; Phone Number: + 39 02.2394; Email: elisa.ciceri@istituto-besta.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a presumptive diagnosis of high-grade glioma scheduled for surgical resection where 5-ALA is used as the standard of care.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-ALA Fluorescence Detection Accuracy	Evaluation of the probe's sensitivity and specificity in detecting 5-ALA fluorescence signals in ex-vivo tumor tissue compared to the gold standard (histopathology/microscope). Measured parameters: operating wavelength interval, resolution, power range.	Day of surgery (intra-operative ex-vivo analysis)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Vessel Identification	Ability of the probe (using ultrasound/Raman) to detect microvessels in the ex-vivo sample, correlated with histological microvessel density.	Day of surgery
Tumor Cell Density Correlation	Correlation between the optical signal intensity and the tumor cell density assessed by pathology.	Day of surgery

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Collaborators: Federico II University
• Investigators: Principal Investigator: Elisa Ciceri, Fondazione IRCCS Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Glioma; 5-ALA; Fluorescence Guided Surgery; Raman Spectroscopy; Stereotactic Biopsy; Fiber Opticts; Nashold Needle
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: FESS; PNRR-POC-2023-12377657 (Other Grant/Funding Number: Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Sponsor (Fondazione IRCCS Istituto Neurologico Carlo Besta) is the owner of the data resulting from the study. Dissemination of information or data requires the prior written consent of the Sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No