Identification of Nerves Using Fluorescein Sodium

Launched by STANFORD UNIVERSITY · Sep 19, 2023

Keywords

ClinConnect Summary

This Stanford study is testing whether giving an intravenous dye called fluorescein sodium during open head-and-neck surgery (such as parotid gland procedures for benign tumors) helps surgeons see nerves more clearly. About 30 adults are expected to enroll. To be eligible, you must be 18 or older, not pregnant, and scheduled for open neck surgery. You should not participate if you have a history of allergic reactions to fluorescein, kidney disease, or other medical conditions that would prevent you from participating. The study design is single-group and open-label, meaning everyone receives the dye.

If you participate, the dye is given after you are under anesthesia, and surgeons will use special imaging to visualize nerves during the operation. Researchers will assess how well the fluorescence matches nerve activity and the surgeon’s visual nerve detection, using a simple 1–4 scale, and will also compare nerve fluorescence to surrounding tissue. They will also look at the total dye dose given (mg/kg) and how long it takes to see the nerves after the dye is given. The study is led by Stanford with support from the NIH’s NIDCD and is currently enrolling by invitation, with results expected around 2025.

Gender

ALL

Eligibility criteria

• 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