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

Mayo Clinic12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Vestibular Schwannoma

Interventions

Fluorescein SodiumDRUG

Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.

YELLOW560 filterDEVICE

Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patient with a suspected VS * Recurrent VS with prior microsurgical resection or radiation therapy * Clinical indication for microsurgical resection Exclusion Criteria * History of allergy to FS * History of renal failure * Pregnant women * Those with inability to give informed consent * Prisoners and inmates

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Surgeon Predicted Use of Fluorescein Sodium in Future Cases

Physician response to surgeon survey question, "Based on the use and performance of FS in this case alone, how likely are you to use FS in future cases (excluding the research trial) involving this tumor?" using a Likert-style rating from 0-4 where 0=Unsure; 1= Plan to not use in any cases; 2= Plan to use in select cases; 3=Plan to use in the majority of cases; 4=Plan to use in all cases.

Time frame: Approximately 3 months postoperatively

Correlation of Fluorescein Sodium With Surgeons' Visual Assessment

Fluorescence correlate with surgeons' visual assessment of the tumor and nerve tissue under normal microscopy without the Yellow 560 filter using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

Time frame: Intraoperatively, approximately 1 day

Correlation of Fluorescein Sodium With Electrostimulation

Surgeons' assessment of fluorescence correlate with electrostimulation (e.g. tissues with high fluorescence do not stimulate, whereas nerve tissues with low fluorescence do stimulate)" using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

Time frame: Intraoperatively, approximately 1 day

Secondary Outcomes

Time to Differential Visualization

The amount of time in minutes for differential visualization of the tumor and surrounding tissue after sodium fluorescein administration during surgery

Time frame: Intraoperatively, approximately 1 day

Average Dose of Sodium Fluorescein Administration

Average dose of sodium fluorescein administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.