Fluorescence Enhanced Stereotactic Surgery (FESS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who are not suitable for surgery
Patients unable to provide informed consent due to cognitive impairment or other reasons
Trial population
Patients with a presumptive diagnosis of high-grade glioma scheduled for surgical resection where 5-ALA is used as the standard of care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
5-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)Secondary outcomes
1
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 surgery2
Tumor Cell Density Correlation
Correlation between the optical signal intensity and the tumor cell density assessed by pathology.
Time frame
Day of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
Federico II University
Collaborator
Source ClinicalTrials.gov