IV sodium fluorescein to highlight suspected CNS tumors during surgery
Official title: Use of i.v. Sodium Fluorescein as a Fluorescent Intra-operative Tracer in Patients With Suspected Malignant Neoplasms of the CNS
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT07233954 · Data updated 2026-11-12
This study tests whether giving a small IV dose of sodium fluorescein during surgery helps surgeons see and remove suspected malignant brain and spinal tumors in people of any age.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | January 13, 2016 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07233954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People of any age with a contrast-enhancing suspected aggressive CNS lesion on pre-operative MRI or CT who can give informed consent and do not have listed exclusions are ideal candidates.
✕Probably not a fit
Patients with non–contrast-enhancing or diffuse infiltrative tumors, those with known severe allergy to fluorescein or contrast agents, recent myocardial infarction or stroke, severe renal or hepatic failure, or women in the first trimester of pregnancy or who are lactating may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The FLUO.CER.TUM study is a prospective observational project at the IRCCS Istituto Neurologico Carlo Besta in Milan enrolling about 800 patients with contrast-enhancing suspected aggressive CNS lesions. Each participant receives 5 mg/kg of intravenous sodium fluorescein at induction of anesthesia and undergoes fluorescence-guided resection using a surgical microscope equipped with a dedicated fluorescence filter. Pre- and post-operative imaging and clinical/neurological evaluations are performed to document extent of resection and perioperative outcomes. Safety data and intraoperative observations are collected without altering standard surgical management.
Why it matters
Potential benefit: If successful, this approach could help surgeons remove more tumor tissue while better sparing healthy brain, potentially improving clinical outcomes.
How similar studies have gone: Previous observational and some comparative studies have reported improved intraoperative tumor visualization and greater extent of resection with fluorescein in contrast-enhancing brain tumors, though randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy Recruiting
Study contacts
- Principal investigator: Morgan A Broggi, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.