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Fluorescence Enhanced Stereotactic Surgery (FESS)

RECRUITINGSponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Actively Recruiting
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Started2024-07-01
Est. completion2026-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07286903

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerHigh Grade GliomaHigh Grade Glioma (III or IV)

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