NCT04351373

Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if there is benefit to using an IV contrast called AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.

Conditions

• Vestibular Schwannoma

Interventions

Type	Name	Description
DRUG	Fluorescein Sodium	Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
DEVICE	YELLOW560 filter	Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2020-04-17
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study