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

Recruitingn/aAges any - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT07233954 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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