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NCT Number: NCT07499141

Use of Fluorescence in 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.

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Key information

Conditions

High Grade Glioma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Trial Center, Alessandria, Piedmont 151121

Alessandria, Italy, 15121

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Data Collection

Other

Data are retrospectively extracted from electronic medical records, histopathological reports, surgical logs, and discharge summaries.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neurological Status

    Time frame: From preoperative assessment to immediate postoperative assessment

    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.

  2. Patient Characteristic

    Time frame: From preoperative assessment to immediate postoperative assessment

    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)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

Use of Fluorescence in High-Grade Gliomas

Acronym: UFGAG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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