Fluorescence-enhanced stereotactic biopsy needle for tumor and vessel detection
Official title: Fluorescence Enhanced Stereotactic Surgery
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT07286903 · Data updated 2026-11-12
This project will test a biopsy needle fitted with 5-ALA fluorescence, Raman spectroscopy, and ultrasound to see if it can identify tumor tissue and blood vessels in adults with high-grade glioma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | July 2026 |
| Study ends | December 2026 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07286903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) undergoing surgical resection for a suspected high-grade glioma who will receive 5-ALA and can provide informed consent are appropriate candidates.
✕Probably not a fit
Patients who are not surgical candidates, cannot receive 5-ALA, or cannot provide informed consent are unlikely to benefit from this ex-vivo device testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multicenter observational project develops a fiber-optic probe integrated into a standard Nashold stereotactic biopsy needle. The device combines 5-ALA–driven fluorescence, Raman spectroscopy, and ultrasound imaging to provide real-time signals intended to distinguish tumor tissue from normal brain and to identify vascular structures. Ex-vivo testing will be performed on resected intra-axial high-grade glioma samples, with probe readings correlated to histopathology across phased development. The program moves from prototyping through phantom and tissue testing to optimization and final validation using approximately 20 tumor samples.
Why it matters
Potential benefit: If successful, this technology could reduce non-diagnostic biopsies and lower the risk of hemorrhage by helping clinicians better identify tumor margins and nearby blood vessels.
How similar studies have gone: 5-ALA fluorescence is an established aid in glioma surgery, but combining fluorescence with Raman spectroscopy and ultrasound inside a biopsy needle is novel and has only limited prior validation in patient-derived tissues.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy Recruiting
Study contacts
- Principal investigator: Elisa Ciceri — Fondazione IRCCS Istituto Neurologico Carlo Besta
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.