Intraoperative Use of I.V. Sodium Fluorescein in Suspected CNS Tumors (FLUOCERTUM)

February 9, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Use of i.v. Sodium Fluorescein as a Fluorescent Intra-operative Tracer in Patients With Suspected Malignant Neoplasms of the CNS

The FLUO.CER.TUM study is a prospective observational clinical trial conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan, Italy. It investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of suspected malignant tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans.

Malignant brain tumors are notoriously difficult to fully resect due to challenges in distinguishing tumor margins from healthy tissue. Sodium fluorescein, a dye that accumulates in areas where the blood-brain barrier is disrupted, offers a promising solution by enhancing tumor visualization during surgery. When used with a dedicated surgical microscope equipped with a fluorescence filter, fluorescein can help surgeons identify and remove more tumor tissue, potentially improving patient outcomes.

The study aims to evaluate the effectiveness and safety of fluorescein-guided surgery in a real-world clinical setting. Approximately 800 patients of any age and gender, with suspected aggressive CNS lesions, will be enrolled. Each patient will receive 5 mg/kg of sodium fluorescein intravenously at the induction of anesthesia. Surgery will be performed using fluorescence-guided techniques, and patients will undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations will also be conducted to monitor outcomes and any adverse effects.

The primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include measuring the extent of tumor resection, evaluating post-operative neurological function, and documenting any side effects related to fluorescein administration.

The study adheres to ethical standards, including informed consent and approval by an ethics committee, and will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Data will be anonymized and securely stored, with results potentially published following appropriate review and approval.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This clinical study investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of aggressive tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans. The study is conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan and follows a prospective observational design.

Malignant CNS tumors are often difficult to completely remove due to the challenge of distinguishing tumor margins from healthy brain tissue. This limitation affects prognosis, especially in high-grade gliomas. Sodium fluorescein, a dye historically used in ophthalmology, accumulates in areas where the blood-brain barrier is disrupted-such as in aggressive brain tumors-making it a potentially ideal agent for enhancing intraoperative visualization. When used with a surgical microscope equipped with a dedicated fluorescence filter, fluorescein allows surgeons to better identify tumor tissue during resection.

The study includes approximately 800 patients of any age and gender, all presenting with suspected aggressive CNS lesions based on contrast-enhanced imaging. Each patient receives 5 mg/kg of sodium fluorescein intravenously at the induction of anesthesia. Surgery is performed using fluorescence-guided techniques, and patients undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations are conducted before and after surgery, with follow-up extending to the third post-operative day.

The primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include evaluating the extent of tumor resection based on early post-operative imaging, monitoring neurological outcomes, and documenting any adverse reactions to fluorescein. Safety parameters such as blood pressure, heart rate, oxygen saturation, temperature, and renal function are monitored according to guidelines from the Italian Medicines Agency (AIFA).

Ethical approval is obtained from the appropriate Ethics Committee, and all patients provide informed consent prior to participation. The study complies with Good Clinical Practice (GCP) and the Declaration of Helsinki. Data are anonymized and stored securely, and results may be published following review and approval by the involved parties.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of both genders, at any age.

Description

Inclusion Criteria:

  1. Patients of both genders, at any age.
  2. Patients with suspected aggressive lesion of the CNS, as suggested by pre-operative MRI or CT with i.v. contrast agent administration.

Exclusion Criteria:

  1. Impossibility to give consent due to cognitive deficits or language disorder.
  2. Known allergy to contrast agents and/or history of previous anaphylactic shocks.
  3. Known severe previous adverse reactions to Fluorescein
  4. Acute myocardial infarction or stroke in the last 90 days.
  5. Severe renal failure;
  6. Severe hepatic failure;
  7. Women in their first trimester of pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Fluorescence Characteristics: Fluorescence Intensity of CNS Tumors
Time Frame: During surgical procedure

Fluorescence intensity of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope.

Metric: Visual intensity of fluorescence in relation to tumor margins (measured on a standardized scale).
During surgical procedure
Intraoperative Fluorescence Characteristics: Fluorescence Distribution of CNS Tumors
Time Frame: During surgery

Fluorescence distribution of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope.

Metric: Spatial distribution of fluorescence relative to tumor margins (e.g., focal vs. diffuse)
During surgery
Intraoperative Fluorescence Characteristics: Fluorescence Clarity of CNS Tumors
Time Frame: During surgery

Fluorescence clarity of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope.

Metric: Sharpness/definition of fluorescence edges in relation to tumor margins (scored visually)
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of Tumor Resection
Time Frame: Within 72 hours post-surgery

Quantitative evaluation of the percentage of tumor removed, based on early post-operative MRI or CT with contrast.

Metric: Volume of residual tumor compared to pre-operative imaging.
Within 72 hours post-surgery
Post-operative Neurological Function
Time Frame: Within 72 hours post-surgery

Description: Assessment of neurological status following surgery, including motor, sensory, and cognitive functions.

Metric: Standard neurological examination scores.
Within 72 hours post-surgery
Adverse Reactions to Fluorescein
Time Frame: Up to 3 days post-surgery

Monitoring and documentation of any side effects or adverse events related to the administration of sodium fluorescein.

Metric: Incidence and severity of adverse events (e.g., allergic reactions, renal/hepatic changes)
Up to 3 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Investigators

  • Principal Investigator: Morgan A Broggi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2016

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUO.CER.TUM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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