Identification of Nerves Using Fluorescein Sodium

Phase 2

• Conditions: Pleomorphic Adenoma of the Parotid; Warthin Tumor; Head and Neck Disorder; Head and Neck; Thyroid Disease; Thyroidectomy
• Interventions: Drug: Fluorescein Sodium

• Registration Number: NCT06054178
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Status Verified: 2024-11
• Study Start: 2024-11-07
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescein sodium during surgery	Fluorescein Sodium	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

Primary Outcome Measures

Name	Time	Method
Facial nerve correlation of Fluorescein Sodium With Electrostimulation	Intraoperative	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	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	Ratio of nerve fluorescence intensity compared to background fluorescence intensity

Secondary Outcome Measures

Name	Time	Method
Average Dose of Sodium Fluorescein Administration	Intraoperative	Average dose of sodium fluorescein administered in mg/kg
Time to Nerve Visualization	Intraoperative	Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration

Trial Locations

Locations (1)

Stanford Medical Center; 🇺🇸 Palo Alto, California, United States