Use of Fluorescence in Gliomas

NCT07499141 | Completed

• 1 other identifier: ASO.Nch.25.03
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

High Grade Glioma; Glioblastoma; Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  From preoperative MRI to immediate postoperative MRI

Secondary Outcomes (2)

• Neurological Status

  From preoperative assessment to immediate postoperative assessment

• Patient Characteristic

  From preoperative assessment to immediate postoperative assessment

Study Arms (2)

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

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.

Other: data collection

Interventions

data collection OTHER

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

Conventional Surgery Group; Fluorescence-Guided Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients hospitalized at the AOU AL (Neurosurgery Department) and undergoing surgical removal of a brain lesion compatible with ICD-9 diagnosis:
• MALIGNANT TUMORS OF THE BRAIN
• MALIGNANT TUMORS OF THE FRONTAL LOBE
• MALIGNANT TUMORS OF THE TEMPORAL LOBE
• MALIGNANT TUMORS OF THE PARIETAL LOBE
• MALIGNANT TUMORS OF THE OCCIPITAL LOBE
• MALIGNANT TUMORS OF THE BRAIN, UNSPECIFIED
• Signing of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

Clinical Trial Center, Alessandria, Piedmont 151121

Alessandria, Italy, 15121, Italy

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Brain Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 30, 2026
• Study Start: September 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 31, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)