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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of procedure, approximately 1 day

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

Fever

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,162 Total Patients Enrolled

Tulio Valdez, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Fluorescein sodium a hazardous substance to patients during surgical procedures?

"By assessing the safety data, our team awarded fluorescein sodium a rating of 2 since this is a phase two trial. There are some indications regarding its safety but no proof that it can effectively treat any medical conditions."

Answered by AI

Are new participants being recruited for this research endeavor?

"According to clinicaltrials.gov, the enrollment period for this trial has ended: it was initially posted on March 1st 2024 and last revised on September 19th 2023. Although patients can't join this study anymore, there are 79 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identification of Nerves Using Fluorescein Sodium

Tulio Valdez 2024. "Identification of Nerves Using Fluorescein Sodium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054178.