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Identification of Nerves Using Fluorescein Sodium

Primary Purpose

Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluorescein Sodium
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pleomorphic Adenoma of the Parotid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluorescein sodium during surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
Ratio of Nerve Fluorescence compared to Background Tissue
Ratio of nerve fluorescence intensity compared to background fluorescence intensity

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2023
Last Updated
September 19, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT06054178
Brief Title
Identification of Nerves Using Fluorescein Sodium
Official Title
Intraoperative Nerve Identification With Fluorescein Sodium
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluorescein sodium during surgery
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fluorescein Sodium
Other Intervention Name(s)
AK-Fluor
Intervention Description
Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg
Primary Outcome Measure Information:
Title
Facial nerve correlation of Fluorescein Sodium With Electrostimulation
Description
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
Time Frame
Day of Procedure, approximately 1 day
Title
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of nerve
Description
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.
Time Frame
Day of Procedure, approximately 1 day
Title
Ratio of Nerve Fluorescence compared to Background Tissue
Description
Ratio of nerve fluorescence intensity compared to background fluorescence intensity
Time Frame
Day of Procedure, approximately 1 day
Secondary Outcome Measure Information:
Title
Average Dose of Sodium Fluorescein Administration
Description
Average dose of sodium fluorescein administered in mg/kg
Time Frame
Day of Procedure, approximately 1 day
Title
Time to Nerve Visualization
Description
Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration
Time Frame
Day of Procedure, approximately 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tulio Valdez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Identification of Nerves Using Fluorescein Sodium

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