Identification of Nerves Using Fluorescein Sodium

Head and Neck Disorder Clinical Trial

Official title:

Intraoperative Nerve Identification With Fluorescein Sodium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06054178
• Other study ID #: 71857
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Pleomorphic
• Head and Neck Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Medical Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day of Procedure, approximately 1 day
Primary	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.	Day of Procedure, approximately 1 day
Primary	Ratio of Nerve Fluorescence compared to Background Tissue	Ratio of nerve fluorescence intensity compared to background fluorescence intensity	Day of Procedure, approximately 1 day
Secondary	Average Dose of Sodium Fluorescein Administration	Average dose of sodium fluorescein administered in mg/kg	Day of Procedure, approximately 1 day
Secondary	Time to Nerve Visualization	Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration	Day of Procedure, approximately 1 day