Fluorescence Enhanced Stereotactic Surgery (FESS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: High Grade Glioma, High Grade Glioma (III or IV). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fluorescence Enhanced Stereotactic Surgery
Overview
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.
Detailed description
'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.
Primary outcome measures
- 5-ALA Fluorescence Detection Accuracy [Time frame: Day of surgery (intra-operative ex-vivo analysis)]
Secondary outcome measures (2)
- Blood Vessel Identification [Time frame: Day of surgery]
- Tumor Cell Density Correlation [Time frame: Day of surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
Identifiers
NCT: NCT07286903 · FESS · PNRR-POC-2023-12377657