Study of Fluorescence Enhanced Stereotactic Surgery Using a Fiber Optic Probe for Safer and More Accurate Biopsy of High Grade Glioma

What this Trial Is About

Researchers are evaluating a new fiber optic system designed to improve the safety and accuracy of brain tumor biopsies in patients with high-grade glioma. This observational study focuses on developing and validating a device integrated into a standard Nashold biopsy needle that combines 5-ALA fluorescence, Raman spectroscopy, and ultrasound imaging. The goal is to provide real-time feedback on tumor tissue and blood vessels during biopsy procedures, addressing risks and limitations of current stereotactic biopsy methods. The study consists of three phases first, developing and prototyping the fiber optic probes and integrating them into the biopsy needle second, testing the system in vitro on phantoms and ex-vivo on brain tumor tissues removed during surgery and third, optimizing and validating the system using about 20 surgical samples of high-grade glioma. During ex-vivo testing, the probe is inserted into resected tumor samples to detect fluorescence and vascular signals, correlating findings with histopathology. Participants will be patients undergoing standard surgery with 5-ALA guidance for high-grade glioma. Researchers will assess the accuracy of 5-ALA fluorescence detection, the identification of blood vessels, and correlation with tumor cell density. The study includes careful analysis of tissue samples to evaluate the devices ability to distinguish tumor margins and vascular structures, aiming to reduce biopsy complications. The trial is expected to conclude in December 2026.

Fluorescence Enhanced Stereotactic Surgery (FESS)