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

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 conducte…

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