NCT03752203

Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 31 Days – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Neurosurgical Tumors

Interventions

Type	Name	Description
DRUG	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
DEVICE	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.

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2018-11-23
• Last updated: 2025-03-06
• Results posted: 2024-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study