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

NCT07233954 | Recruiting

• 1 other identifier: FLUO.CER.TUM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CNS

Keywords

Neurosurgical Procedures; Malignant Neoplasms; Surgical Margins; Fluorescein

Outcome Measures

Primary Outcomes (3)

• Intraoperative Fluorescence Characteristics: Fluorescence Intensity of CNS Tumors

  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

  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

  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 Outcomes (3)

• Extent of Tumor Resection

  Within 72 hours post-surgery

• Post-operative Neurological Function

  Within 72 hours post-surgery

• Adverse Reactions to Fluorescein

  Up to 3 days post-surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of both genders, at any age.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Morgan A Broggi, MD

  Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: January 13, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)