Fluorescence Enhanced Stereotactic Surgery

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Collaborators: Federico II University
Leads: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

This content was sourced from clinicaltrials.gov