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NCT Number: NCT07286903

Fluorescence Enhanced Stereotactic Surgery (FESS)

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.

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Key information

Conditions

High Grade Glioma Glioma High Grade Glioma (III or IV) Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Location status: Recruiting

Location contact

Elisa Ciceri, MD

CONTACT

[email protected]

+ 39 02.2394

About this study

'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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 5-ALA Fluorescence Detection Accuracy

    Time frame: Day of surgery (intra-operative ex-vivo analysis)

    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.

Secondary outcomes

  1. Blood Vessel Identification

    Time frame: Day of surgery

    Ability of the probe (using ultrasound/Raman) to detect microvessels in the ex-vivo sample, correlated with histological microvessel density.

  2. Tumor Cell Density Correlation

    Time frame: Day of surgery

    Correlation between the optical signal intensity and the tumor cell density assessed by pathology.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Federico II University

Registry information

Official study title

Fluorescence Enhanced Stereotactic Surgery

Acronym: FESS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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