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Completed

NCT Number: NCT06054178

Identification of Nerves Using Fluorescein Sodium

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.

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Key information

Conditions

Pleomorphic Adenoma of the Parotid Adenolymphoma Endocrine System Diseases Head and Neck Head and Neck Disorder Neoplasms Neoplasms by Histologic Type Neoplasms, Complex and Mixed Thyroid Disease Thyroid Diseases Thyroidectomy Warthin Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Medical Center

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorescein sodium

Drug

Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg

Other names: FLUORESCITE Injection 10%

Primary outcomes

  1. Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation

    Time frame: 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

  2. Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve

    Time frame: 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.

  3. Ratio of Nerve Fluorescence Compared to Background Tissue

    Time frame: Intraoperative (Day 1, Up to 20 minutes to assess)

    Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity

Secondary outcomes

  1. Average Dose of Sodium Fluorescein Administration

    Time frame: Intraoperative (day 1)

    Average dose of sodium fluorescein administered in mg/kg

  2. Time to Nerve Visualization

    Time frame: Intraoperative (day 1, up to approximately 200 minutes for initial imaging)

    Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Intraoperative Nerve Identification With Fluorescein Sodium

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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