Actively Recruiting
Fluorescence Enhanced Stereotactic Surgery for High Grade Glioma Using an Integrated Fiber Optic Biopsy Needle
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2025-12-16
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
F
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
F
Federico II University
Collaborating Sponsor
AI-Summary
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 device's ability to distinguish tumor margins and vascular structures, aiming to reduce biopsy complications. The trial is expected to conclude in December 2026.
CONDITIONS
Brief Title
Fluorescence Enhanced Stereotactic Surgery (FESS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Able to provide informed consent
- Presumptive diagnosis of high-grade glioma
- Surgery planned using 5-ALA as standard treatment
You will not qualify if you...
- Not suitable for surgery
- Unable to provide informed consent due to cognitive impairment or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during screening and enrollment visit
Duration - Day of surgery
Participants undergo surgery using 5-ALA fluorescence as part of standard treatment. During surgery, the integrated fiber optic biopsy needle is used for ex-vivo analysis of resected tumor tissue to detect fluorescence and blood vessels.
1 visit (in-person) on the day of surgery
Duration - Duration varies based on routine care
Participants are observed after surgery for any post-operative assessments as part of routine care.
Visit schedule depends on routine clinical care
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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