Fluorescence Enhanced Stereotactic Surgery (FESS)

Recruiting now

Conditions studied: High Grade Glioma, High Grade Glioma (III or IV)

In brief

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.

Key facts

Study ID

NCT07286903

Run by

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

People needed

20

Starts

2024-07-01

Expected to finish

2026-12-01

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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