Fluorescence-enhanced stereotactic biopsy needle for tumor and vessel detection
Fluorescence Enhanced Stereotactic Surgery
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07286903 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Elisa Ciceri — Fondazione IRCCS Istituto Neurologico Carlo Besta
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.