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Fluorescein Sodium for Nerve Identification in Head and Neck Surgery

Phase 2
Waitlist Available
Led By Tulio Valdez, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for open head and neck surgery
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of procedure, approximately 1 day
Awards & highlights

Study Summary

This trial tests using a contrast dye to help find nerves during head and neck surgery, to improve surgical outcomes.

Who is the study for?
This trial is for adults over 18 scheduled for open head and neck surgery. It's not suitable for pregnant individuals, those with a history of adverse reaction to fluorescein, or anyone with severe medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the use of AK-Fluor®, a type of IV contrast called sodium fluorescein, to see if it helps surgeons better identify nerves during head and neck surgeries.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the fluorescein dye used in this procedure. Patients with previous allergies or kidney issues are at higher risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery on my head or neck that involves opening the area.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of procedure, approximately 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of procedure, approximately 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of nerve
Facial nerve correlation of Fluorescein Sodium With Electrostimulation
Ratio of Nerve Fluorescence compared to Background Tissue
Secondary outcome measures
Average Dose of Sodium Fluorescein Administration
Time to Nerve Visualization

Side effects data

From 2022 Phase 2 trial • 12 Patients • NCT04351373
8%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fluorescein sodium during surgeryExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorescein Sodium
2023
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,377 Total Patients Enrolled
Tulio Valdez, MDPrincipal InvestigatorStanford University
~20 spots leftby Dec 2024
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