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Fluorescence Enhanced Stereotactic Surgery (FESS)

Recruitingn/aAges 18 Years - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT07286903 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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