Fluorescence Enhanced Stereotactic Surgery (FESS)

NCT07286903 | Recruiting

• 2 other identifiers: FESSPNRR-POC-2023-12377657
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Stereotactic Biopsy; Fluorescence Guided Surgery; 5-ALA; Raman Spectroscopy; Glioma; Fiber Opticts; Nashold Needle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood Vessel Identification

  Day of surgery

• Tumor Cell Density Correlation

  Day of surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who are not suitable for surgery
• Patients unable to provide informed consent due to cognitive impairment or other reasons

Sponsors & Collaborators

• Federico II University: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

standard IHC and molecular tests

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Elisa Ciceri

  Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)