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Identification of Nerves Using Fluorescein Sodium

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06054178
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluorescein Sodium
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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 intraoperativelyExperimental: 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)
Primary Purpose:
Other
Official Title:
Intraoperative Nerve Identification With Fluorescein Sodium
Anticipated Study Start Date :
Mar 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Fluorescein Sodium
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:
  • AK-Fluor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Facial nerve correlation of Fluorescein Sodium With Electrostimulation [Day of Procedure, approximately 1 day]

      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 [Day of Procedure, approximately 1 day]

      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 [Day of Procedure, approximately 1 day]

      Ratio of nerve fluorescence intensity compared to background fluorescence intensity

    Secondary Outcome Measures

    1. Average Dose of Sodium Fluorescein Administration [Day of Procedure, approximately 1 day]

      Average dose of sodium fluorescein administered in mg/kg

    2. Time to Nerve Visualization [Day of Procedure, approximately 1 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Medical Center Palo Alto California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Tulio Valdez, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tulio Valdez, Professor of Otolaryngology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT06054178
    Other Study ID Numbers:
    • 71857
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Adenoma
    Adenolymphoma
    Adenoma, Pleomorphic

    Study Results

    No Results Posted as of Sep 26, 2023