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.
'The study focuses on the "Fluorescence Enhanced Stereotactic Surgery" (FESS) project. It is a prospective, multicenter, observational study on a device. The study consists of three phases: Phase 1: Development and prototyping of fiber optic probes (by partner CERICT), integration into a standard biopsy needle, and software development. Phase 2: In vitro testing on phantoms and ex-vivo testing on biological tissue. Ex-vivo tests will be performed on intra-axial brain tumor samples resected during standard surgery (guided by 5-ALA fluorescence). The probe will be inserted into the resected sample to detect fluorescence and vascular signals. Results will be correlated with histopathological analysis. Phase 3: Optimization and final validation of the integrated system. Approximately 20 samples of high-grade glioma will be analyzed. The goal is to verify if the probe can distinguish tumor tissue (via 5-ALA fluorescence) and identify blood vessels (via ultrasound/Raman) to prevent hemorrhage during biopsies.
Study Type
OBSERVATIONAL
Enrollment
20
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
RECRUITING5-ALA Fluorescence Detection Accuracy
Evaluation of the probe's sensitivity and specificity in detecting 5-ALA fluorescence signals in ex-vivo tumor tissue compared to the gold standard (histopathology/microscope). Measured parameters: operating wavelength interval, resolution, power range.
Time frame: Day of surgery (intra-operative ex-vivo analysis)
Blood Vessel Identification
Ability of the probe (using ultrasound/Raman) to detect microvessels in the ex-vivo sample, correlated with histological microvessel density.
Time frame: Day of surgery
Tumor Cell Density Correlation
Correlation between the optical signal intensity and the tumor cell density assessed by pathology.
Time frame: Day of surgery
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