Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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.

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

Sodium Fluorescein

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

Microscopic Resection

Todd Hankinson, MD

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.

The primary neurosurgeons who will perform the resections will be investigators on the study and will identify eligible patients from the established practice. At the time surgical intervention is recommended, the doctors will inform patients and parents/guardians of the existence of the study. Only those subjects with a clinical relationship to the study investigators will be recruited.

Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.

Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

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.

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.

University of Colorado, Denver

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

Sodium-Fluorescein Resection

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study was discontinued due to lack of funding and patients.

Dr. Todd Hankinson

Data not collected or analyzed and therefore cannot be reported . Study was terminated due to lack of patients and funding. The Outcome Measure Data Table is not able to be completed due to lack of data.

Percent of Tumor Resected: Intracranial Lesions

Percent of Tumor Resected: Spinal Lesions

No Outcome Measures were completed due to data not collected due to lack of patients and funding.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors	NCT03752203	Pediatric Neuro...	Sodium Fluoresc... Microscopic Res...	31 Days - 21 Years	University of Colorado, Denver
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors	NCT03752203	Pediatric Neuro...	Sodium Fluoresc... Microscopic Res...	31 Days - 21 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for pediatric neurosurgical tumors