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Identification of Nerves Using Fluorescein Sodium

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ClinicalTrials.gov Identifier: NCT06054178
Recruitment Status : Not yet recruiting
First Posted : September 26, 2023
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Tulio Valdez, Stanford University

Study Description
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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
Pleomorphic Adenoma of the Parotid Warthin Tumor Head and Neck Disorder Drug: Fluorescein Sodium Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 intraoperatively
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intraoperative Nerve Identification With Fluorescein Sodium
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

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Arms and Interventions
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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 Name: AK-Fluor


Outcome Measures
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Primary Outcome Measures :
  1. Facial nerve correlation of Fluorescein Sodium With Electrostimulation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day of Procedure, approximately 1 day ]
    Average dose of sodium fluorescein administered in mg/kg

  2. Time to Nerve Visualization [ Time Frame: Day of Procedure, approximately 1 day ]
    Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054178


Locations
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United States, California
Stanford Medical Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Tulio Valdez, MD Stanford University
More Information
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Responsible Party: Tulio Valdez, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT06054178    
Other Study ID Numbers: 71857
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Adenoma
Adenolymphoma
Adenoma, Pleomorphic
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed