Fluorescence Enhanced Stereotactic Surgery (FESS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patients who are not suitable for surgery
Patients unable to provide informed consent due to cognitive impairment or other reasons
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
Federico II University
Collaborator
Source ClinicalTrials.gov