High Grade GliomaFESSNCT07286903
Fluorescence Enhanced Stereotactic Surgery (FESS)
An observational study of High Grade Glioma and High Grade Glioma (III or IV), run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma, High Grade Glioma (III or IV)
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a presumptive diagnosis of high-grade glioma scheduled for surgical resection where 5-ALA is used as the standard of care.
Who may be able to join
- 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
Who cannot join
- Patients who are not suitable for surgery
- Patients unable to provide informed consent due to cognitive impairment or other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Elisa Ciceri, MD, + 39 02.2394, elisa.ciceri@istituto-besta.it
About this study
Official title: Fluorescence Enhanced Stereotactic Surgery
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.
Read the 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.
- Conditions
- High Grade Glioma, High Grade Glioma (III or IV)
- Keywords
- Stereotactic Biopsy, Fluorescence Guided Surgery, 5-ALA, Raman Spectroscopy, Glioma, Fiber Opticts, Nashold Needle
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery (intra-operative ex-vivo analysis)
Secondary outcomes (2)
Blood Vessel Identification
Ability of the probe (using ultrasound/Raman) to detect microvessels in the ex-vivo sample, correlated with histological microvessel density.
Measured: Day of surgery
Tumor Cell Density Correlation
Correlation between the optical signal intensity and the tumor cell density assessed by pathology.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
- Investigators
- Elisa Ciceri, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286903
- Sponsor's protocol ID
- FESS
- Other IDs
- PNRR-POC-2023-12377657
- Acronym
- FESS
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Sponsor (Fondazione IRCCS Istituto Neurologico Carlo Besta) is the owner of the data resulting from the study. Dissemination of information or data requires the prior written consent of the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Enhanced Stereotactic Surgery
- ClinicalTrials.gov ID
- NCT07286903
- Acronym / sponsor ID
- FESS / FESS
- Conditions
- High Grade Glioma, High Grade Glioma (III or IV)
- Keywords
- Stereotactic Biopsy, Fluorescence Guided Surgery, 5-ALA, Raman Spectroscopy, Glioma, Fiber Opticts, Nashold Needle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a presumptive diagnosis of high-grade glioma scheduled for surgical resection where 5-ALA is used as the standard of care.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are not suitable for surgery
- Patients unable to provide informed consent due to cognitive impairment or other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
5-ALA Fluorescence Detection Accuracy
Time frame: Day of surgery (intra-operative ex-vivo analysis)
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.
2 secondary outcomes
Blood Vessel Identification
Time frame: Day of surgery
Tumor Cell Density Correlation
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. The Sponsor (Fondazione IRCCS Istituto Neurologico Carlo Besta) is the owner of the data resulting from the study. Dissemination of information or data requires the prior written consent of the Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Elisa Ciceri principal investigator
Fondazione IRCCS Istituto Neurologico Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Glioma and High Grade Glioma (III or IV), run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-ALA Fluorescence Detection Accuracy (time frame: Day of surgery (intra-operative ex-vivo analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.