Identification of Nerves Using Fluorescein Sodium

Stanford University

Status and phase: Invitation-only; Phase 2

Conditions: Pleomorphic Adenoma of the Parotid; Head and Neck; Head and Neck Disorder; Thyroidectomy; Thyroid Disease; Warthin Tumor

Treatments: Drug: Fluorescein Sodium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06054178

71857

R25DC020174-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Fluorescein sodium during surgery

Experimental group

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

Treatment:

Drug: Fluorescein Sodium