Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

University of Colorado, Denver2 enrolled

Overview

Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.

This study will be a prospective non-randomized cohort study with patients presenting to Children's Hospital Colorado for resection of a central nervous system tumor. This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished blood-brain barrier integrity and allows for determination of the margins between tumor and normal brain function.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pediatric Neurosurgical Tumors

Interventions

Sodium FluoresceinDRUG

Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds

Microscopic ResectionDEVICE

Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.

Eligibility

Sex: ALLMin age: 31 DaysMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 31 days through 21 years on date of surgery * Undergoing resection of a central nervous system tumor at Children's Hospital Colorado * Parent/legal guardian (or adult subject) willing and able to complete the informed consent process Exclusion Criteria: * Tumor in functionally eloquent cortex that precludes maximal surgical resection * Severe renal dysfunction * Preoperative serum creatinine level \> than normal range and GFR \< 30. * Severe liver dysfunction * History of asthma or pulmonary spasm * Known allergy to sodium fluorescein or any other contrast dye * Previous administration of sodium fluorescein within the last 72 hours * Pregnant or nursing mother * Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Percent of Tumor Resected: Intracranial Lesions

For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In intracranial lesions, the use of volumetric imaging tools will be used to calculate the extent of tumor resection.

Time frame: Pre-op assessment to outpatient follow up, up to 6 weeks

Percent of Tumor Resected: Spinal Lesions

For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In spinal lesions, manual measurement will be used to determine the extent of resection.

Time frame: Pre-op assessment to outpatient follow up, up to 6 weeks

Data from ClinicalTrials.gov

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