Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder, Head and Neck, Thyroid Disease, Thyroidectomy
Conditions
Brief summary
The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.
Interventions
Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg
Sponsors
Stanford University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects 2. 18 years or older 3. Scheduled for open head and neck surgery
Exclusion criteria
1. Inability or unwillingness of a subject 2. Pregnancy 3. Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students) 4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study 5. History of adverse reaction to fluorescein including allergy. 6. History of renal failure or chronic kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation | Intraoperative (day 1, up to 1 minute to assess) | 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 |
| Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve | Intraoperative (day 1, up to 1 minute to assess) | 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. |
| Ratio of Nerve Fluorescence Compared to Background Tissue | Intraoperative (Day 1, Up to 20 minutes to assess) | Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Dose of Sodium Fluorescein Administration | Intraoperative (day 1) | Average dose of sodium fluorescein administered in mg/kg |
| Time to Nerve Visualization | Intraoperative (day 1, up to approximately 200 minutes for initial imaging) | Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTulio Valdez, MD
Stanford University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 20.3 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Non-white hispanic | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
None listed