Identification of Nerves Using Fluorescein Sodium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) called AK-Fluor® to identify nerves during head and neck surgery.

Official Title
-----------------
Intraoperative Nerve Identification With Fluorescein Sodium

Conditions
-----------------
Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder

Intervention / Treatment
-----------------
* Drug: Fluorescein Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18 years or older Scheduled for open head and neck surgery Exclusion Criteria: Inability or unwillingness of a subject Pregnancy Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students) Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study History of adverse reaction to fluorescein including allergy. History of renal failure or chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Experimental: Fluorescein sodium during surgery Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescein sodium during surgery<br>Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively | Drug: Fluorescein Sodium<br>* Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg<br>* Other names: AK-Fluor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial nerve correlation of Fluorescein Sodium With Electrostimulation | Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation | Day of Procedure, approximately 1 day | 
| Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of nerve | Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation. | Day of Procedure, approximately 1 day | 
| Ratio of Nerve Fluorescence compared to Background Tissue | Ratio of nerve fluorescence intensity compared to background fluorescence intensity | Day of Procedure, approximately 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Dose of Sodium Fluorescein Administration | Average dose of sodium fluorescein administered in mg/kg | Day of Procedure, approximately 1 day | 
| Time to Nerve Visualization | Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration | Day of Procedure, approximately 1 day |