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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vestibular Schwannoma

Intervention / Treatment
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* Drug: Fluorescein Sodium
* Device: YELLOW560 filter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery<br>Subjects undergoing clinically planned vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma, removal surgery will have contrast agent fluorescein sodium administered intravenously after tumor exposure, and a special filter called YELLOW560 will be used on the operating microscope to see the fluorescent coloring of the contrast. | Drug: Fluorescein Sodium<br>* Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.<br>* Other names: AK-Fluor®;Device: YELLOW560 filter<br>* Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.<br>* Other names: YELLOW 560 nm microscope filter (YE560);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Intraoperatively, approximately 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Intraoperatively, approximately 1 day | 
| Total Resection Rate | Number of subjects to have a gross total resection | Intraoperatively, approximately 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Paraganglioma, Head and Neck Schwannoma