Identification of Nerves Using Fluorescein Sodium

NCT06054178 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 71857R25DC020174-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleomorphic Adenoma of the Parotid; Warthin Tumor; Head and Neck Disorder; Head and Neck; Thyroid Disease; Thyroidectomy

Outcome Measures

Primary Outcomes (3)

• 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

  Intraoperative (day 1, up to 1 minute to assess)

• 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.

  Intraoperative (day 1, up to 1 minute to assess)

• Ratio of Nerve Fluorescence Compared to Background Tissue

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

  Intraoperative (Day 1, Up to 20 minutes to assess)

Secondary Outcomes (2)

• Average Dose of Sodium Fluorescein Administration

  Intraoperative (day 1)

• Time to Nerve Visualization

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

Study Arms (1)

Fluorescein sodium during surgery

EXPERIMENTAL

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

Interventions

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

Also known as: FLUORESCITE Injection 10%

Fluorescein sodium during surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects
• years or older
• Scheduled for open head and neck surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Stanford Medical Center

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Park RK, Arus BA, Lee JY, Weitzenberg MM, Lee MC, Nyaeme MS, Barthel J, Balsamo G, Baik FM, Speirs K, Blume B, Heller-Algazi M, Chmyrov A, Plettenburg O, Megwalu UC, Weitz J, Distler M, Bruns OT, Valdez TA. Intraoperative nerve imaging with sodium fluorescein. medRxiv [Preprint]. 2025 Feb 17:2025.02.08.25321923. doi: 10.1101/2025.02.08.25321923.

  PMID: 40034788 RESULT

MeSH Terms

Conditions

Adenolymphoma; Thyroid Diseases

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Tulio Valdez, MD
• Organization: Stanford University

tvaldez1@stanford.edu

650-724-4800

Study Officials

• Tulio Valdez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Model Details: 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

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: November 7, 2024
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: May 20, 2026
• Results First Posted: May 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)