High Grade GliomaUFGAGNCT07499141
Use of Fluorescence in Gliomas
An observational study of High Grade Glioma and Glioblastoma, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
During brain tumor surgery, it can be difficult for surgeons to distinguish between tumor tissue and healthy brain tissue. To address this challenge, fluorescent agents such as sodium fluorescein or 5-ALA are sometimes used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma, Glioblastoma, Brain Neoplasms
- What is being tested?
- data collection
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A total of 45 patients undergoing surgery for high-grade brain glioma will be enrolled at the Azienda Ospedaliero-Universitaria "SS Antonio e Biagio e Cesare Arrigo" in Alessandria, during the period from June 2023 to March 2024.
Who may be able to join
- Patients hospitalized at the AOU AL (Neurosurgery Department) and undergoing surgical removal of a brain lesion compatible with ICD-9 diagnosis:
- 191 MALIGNANT TUMORS OF THE BRAIN
- 191.1 MALIGNANT TUMORS OF THE FRONTAL LOBE
- 191.2 MALIGNANT TUMORS OF THE TEMPORAL LOBE
- 191.3 MALIGNANT TUMORS OF THE PARIETAL LOBE
- 191.4 MALIGNANT TUMORS OF THE OCCIPITAL LOBE
- 191.9 MALIGNANT TUMORS OF THE BRAIN, UNSPECIFIED
- Signing of informed consent
Who cannot join
- Incomplete electronic records or missing clinical data useful for this study.
- Patients not eligible for surgical intervention
- Patients affected by a neoplasm not compatible with a histological diagnosis of high-grade glioma
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinical Trial Center, Alessandria, Piedmont 151121
Alessandria, Italy, 15121
About this study
Official title: Use of Fluorescence in High-Grade Gliomas
During brain tumor surgery, it can be difficult for surgeons to distinguish between tumor tissue and healthy brain tissue. To address this challenge, fluorescent agents such as sodium fluorescein or 5-ALA are sometimes used. These substances cause the tumor to "glow" under specific lighting conditions, making it easier to visualize.
This study retrospectively analyzes medical records of patients treated at the University Hospital of Alessandria between June 2023 and March 2024. It compares surgeries performed with these fluorescent agents to those performed without them, in order to determine whether fluorescence-guided surgery leads to a higher rate of complete tumor removal (gross total resection), as confirmed by post-operative MRI scans.
The aim is to evaluate how the use of fluorescent dyes (fluorochromes) influences surgical outcomes in patients with high-grade gliomas (aggressive brain tumors). The study will also assess the impact of these tools on operative time, patient safety, and the overall recovery process.
Read the detailed description
High-grade gliomas are aggressive central nervous system tumors characterized by rapid growth and significant infiltration of the surrounding brain tissue. According to the European Association of Neuro-Oncology (EANO) guidelines, the standard of care involves a multimodal approach including surgery, radiotherapy, and chemotherapy. A key surgical goal is achieving Gross Total Resection (GTR), which is often limited by the difficulty of distinguishing tumor margins from functional brain structures.
Fluorescence-guided surgery (FGS), using fluorochromes such as sodium fluorescein (SF) and 5-aminolevulinic acid (5-ALA), has emerged as a valuable tool to enhance intraoperative tumor visualization.
This is a retrospective, observational, single-center study conducted at the Neurosurgery Unit of the Azienda Ospedaliero-Universitaria "SS Antonio e Biagio e Cesare Arrigo" in Alessandria. The primary objective is to evaluate the impact of fluorescence use on the extent of resection (EOR) in patients undergoing surgery for high-grade gliomas. The study compares surgical outcomes between procedures performed with and without the use of fluorescent tracers.
The study includes all patients who underwent surgery for suspected high-grade glioma (ICD-9 codes 191-191.9) between June 2023 and March 2024. Data are retrospectively extracted from electronic medical records, histopathological reports, surgical logs, and discharge summaries.
The extent of resection is assessed through comparative analysis of preoperative and postoperative magnetic resonance imaging (MRI) scans.
Secondary endpoints include: Characterization of epidemiological and clinical profiles, Comparison of preoperative and postoperative neurological status, Assessment of surgical safety and operative time,Identification of adverse effects and progression-free survival (PFS).
Descriptive statistics are used to summarize patient characteristics. Continuous variables are expressed as mean (standard deviation) or median (interquartile range), while categorical variables are presented as frequencies and percentages. Univariate analyses (Chi-square test, Fisher's exact test, or ANOVA) are performed to identify covariates for subsequent multivariate regression models. Statistical significance is set at p ≤ 0.05.
Data management is conducted using the REDCap (Research Electronic Data Capture) platform, ensuring compliance with GDPR and Italian data protection regulations.
- Conditions
- High Grade Glioma, Glioblastoma, Brain Neoplasms
- Being tested
- data collection
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Data are retrospectively extracted from electronic medical records, histopathological reports, surgical logs, and discharge summaries.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence-Guided Surgery Group | This cohort includes patients who underwent neurosurgical resection with the aid of fluorescence-guided surgery. In these cases, fluorochromes (such as sodium fluorescein and/or 5-aminolevulinic acid [5-ALA]) were used to enhance intraoperative visualization of tumor tissue and facilitate its resection Receives: Other: data collection | |
| Conventional Surgery Group | This cohort includes patients who underwent neurosurgical tumor resection using standard microsurgical techniques without the use of fluorochromes. Tumor removal was performed based on anatomical and neuroradiological information and the surgeon's expertise, without fluorescence guidance. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the extent of tumor mass resection
To evaluate the extent of tumor mass resection in patients undergoing surgery, based on the comparison of preoperative and postoperative magnetic resonance imaging (MRI) scans.
Measured: From preoperative MRI to immediate postoperative MRI
Secondary outcomes (2)
Neurological Status
Comparison of patients' neurological status before and after surgery to assess the onset or worsening of neurological deficits using preoperative and intraoperative brain mapping, a set of procedures that allow a specific neurological function to be correlated with a specific area of the brain.
Measured: From preoperative assessment to immediate postoperative assessment
Patient Characteristic
Description of the baseline characteristics of patients undergoing neurosurgical resection for a brain lesion compatible with high-grade glioma, osservazione and clinical observation of patients during the postoperative hospital stay, with particular attention to the presence of early complications (early bleeding, surgical site infections, seizures)
Measured: From preoperative assessment to immediate postoperative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Sep 2025
- Primary completion15 Oct 2025
- Study completion31 Dec 2025
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
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499141
- Sponsor's protocol ID
- ASO.Nch.25.03
- Acronym
- UFGAG
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fluorescence in High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT07499141
- Acronym / sponsor ID
- UFGAG / ASO.Nch.25.03
- Conditions
- High Grade Glioma, Glioblastoma, Brain Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Mar 2026 (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.
During brain tumor surgery, it can be difficult for surgeons to distinguish between tumor tissue and healthy brain tissue. To address this challenge, fluorescent agents such as sodium fluorescein or 5-ALA are sometimes used. These substances cause the tumor to "glow" under specific lighting conditions, making it easier to visualize.
This study retrospectively analyzes medical records of patients treated at the University Hospital of Alessandria between June 2023 and March 2024. It compares surgeries performed with these fluorescent agents to those performed without them, in order to determine whether fluorescence-guided surgery leads to a higher rate of complete tumor removal (gross total resection), as confirmed by post-operative MRI scans.
The aim is to evaluate how the use of fluorescent dyes (fluorochromes) influences surgical outcomes in patients with high-grade gliomas (aggressive brain tumors). The study will also assess the impact of these tools on operative time, patient safety, and the overall recovery process.
Detailed description
High-grade gliomas are aggressive central nervous system tumors characterized by rapid growth and significant infiltration of the surrounding brain tissue. According to the European Association of Neuro-Oncology (EANO) guidelines, the standard of care involves a multimodal approach including surgery, radiotherapy, and chemotherapy. A key surgical goal is achieving Gross Total Resection (GTR), which is often limited by the difficulty of distinguishing tumor margins from functional brain structures.
Fluorescence-guided surgery (FGS), using fluorochromes such as sodium fluorescein (SF) and 5-aminolevulinic acid (5-ALA), has emerged as a valuable tool to enhance intraoperative tumor visualization.
This is a retrospective, observational, single-center study conducted at the Neurosurgery Unit of the Azienda Ospedaliero-Universitaria "SS Antonio e Biagio e Cesare Arrigo" in Alessandria. The primary objective is to evaluate the impact of fluorescence use on the extent of resection (EOR) in patients undergoing surgery for high-grade gliomas. The study compares surgical outcomes between procedures performed with and without the use of fluorescent tracers.
The study includes all patients who underwent surgery for suspected high-grade glioma (ICD-9 codes 191-191.9) between June 2023 and March 2024. Data are retrospectively extracted from electronic medical records, histopathological reports, surgical logs, and discharge summaries.
The extent of resection is assessed through comparative analysis of preoperative and postoperative magnetic resonance imaging (MRI) scans.
Secondary endpoints include: Characterization of epidemiological and clinical profiles, Comparison of preoperative and postoperative neurological status, Assessment of surgical safety and operative time,Identification of adverse effects and progression-free survival (PFS).
Descriptive statistics are used to summarize patient characteristics. Continuous variables are expressed as mean (standard deviation) or median (interquartile range), while categorical variables are presented as frequencies and percentages. Univariate analyses (Chi-square test, Fisher's exact test, or ANOVA) are performed to identify covariates for subsequent multivariate regression models. Statistical significance is set at p ≤ 0.05.
Data management is conducted using the REDCap (Research Electronic Data Capture) platform, ensuring compliance with GDPR and Italian data protection regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence-Guided Surgery Group | – | Other: data collectionThis cohort includes patients who underwent neurosurgical resection with the aid of fluorescence-guided surgery. In these cases, fluorochromes (such as sodium fluorescein and/or 5-aminolevulinic acid [5-ALA]) were used to enhance intraoperative visualization of tumor tissue and facilitate its resection |
| Conventional Surgery Group | – | Other: data collectionThis cohort includes patients who underwent neurosurgical tumor resection using standard microsurgical techniques without the use of fluorochromes. Tumor removal was performed based on anatomical and neuroradiological information and the surgeon's expertise, without fluorescence guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 45 patients undergoing surgery for high-grade brain glioma will be enrolled at the Azienda Ospedaliero-Universitaria "SS Antonio e Biagio e Cesare Arrigo" in Alessandria, during the period from June 2023 to March 2024.
Key inclusion criteria (8 listed)
- Patients hospitalized at the AOU AL (Neurosurgery Department) and undergoing surgical removal of a brain lesion compatible with ICD-9 diagnosis:
- 191 MALIGNANT TUMORS OF THE BRAIN
- 191.1 MALIGNANT TUMORS OF THE FRONTAL LOBE
- 191.2 MALIGNANT TUMORS OF THE TEMPORAL LOBE
- 191.3 MALIGNANT TUMORS OF THE PARIETAL LOBE
Key exclusion criteria (3 listed)
- Incomplete electronic records or missing clinical data useful for this study.
- Patients not eligible for surgical intervention
- Patients affected by a neoplasm not compatible with a histological diagnosis of high-grade glioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionData are retrospectively extracted from electronic medical records, histopathological reports, surgical logs, and discharge summaries. | Other | Conventional Surgery Group, Fluorescence-Guided Surgery Group |
Primary outcome
Evaluate the extent of tumor mass resection
Time frame: From preoperative MRI to immediate postoperative MRI
To evaluate the extent of tumor mass resection in patients undergoing surgery, based on the comparison of preoperative and postoperative magnetic resonance imaging (MRI) scans.
2 secondary outcomes
Neurological Status
Time frame: From preoperative assessment to immediate postoperative assessment
Patient Characteristic
Time frame: From preoperative assessment to immediate postoperative assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Glioblastoma, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the extent of tumor mass resection (time frame: From preoperative MRI to immediate postoperative MRI). 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 30 Mar 2026.