Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Not Applicable

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sodium-Fluorescein Resection	Sodium Fluorescein	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.
Sodium-Fluorescein Resection	Microscopic Resection	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.

Primary Outcome Measures

Name	Time	Method
Percent of Tumor Resected: Intracranial Lesions	Pre-op assessment to outpatient follow up, up to 6 weeks	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.
Percent of Tumor Resected: Spinal Lesions	Pre-op assessment to outpatient follow up, up to 6 weeks	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.

Secondary Outcome Measures