Fluorescein Sodium for Nerve Identification in Head and Neck Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Pregnancy, Renal failure, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether fluorescein sodium, a special dye, can help doctors see nerves more clearly during head and neck surgery. The main goal is to make these surgeries safer and more precise by highlighting nerves, which are often difficult to spot. Suitable participants are those scheduled for open head and neck surgery without a history of kidney issues or allergies to the dye. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in surgical safety and precision.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that fluorescein sodium is safe for nerve identification in head and neck surgery?

Research has shown that fluorescein sodium is usually safe for use in surgeries. One study found that it helps doctors see nerves more clearly during surgery, enhancing safety. This clarity can prevent nerve damage, which might lead to issues like difficulty swallowing or changes in voice. Another study also confirmed that using fluorescein sodium in surgery is safe and effective for better nerve identification.

Although fluorescein sodium is not yet officially approved for nerve identification in surgeries, it has been tested in other medical situations, supporting its safety. So far, these studies have reported no major serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for nerve identification in head and neck surgery rely on the surgeon’s skill and experience, often using anatomical landmarks and traditional visualization techniques. However, fluorescein sodium is unique because it is administered intravenously and allows for enhanced visualization of nerves through fluorescence imaging during surgery. This new approach helps surgeons identify nerves more clearly, potentially reducing the risk of nerve damage and improving surgical outcomes. Researchers are excited about this method because it offers a more precise and real-time way to protect nerves compared to traditional methods.

What evidence suggests that fluorescein sodium is effective for nerve identification in head and neck surgery?

Research has shown that fluorescein sodium can help surgeons see nerves better during operations. In this trial, participants undergoing parotid surgery for benign conditions will receive fluorescein sodium intravenously after induction, and fluorescence imaging will visualize nerves intraoperatively. One study found that fluorescein sodium made the nerves stand out more compared to regular lighting. This enhanced visibility allows surgeons to see the nerves more clearly, potentially preventing nerve damage during surgery. Although more research is needed, early results suggest it could make head and neck surgeries safer. ^{2 3 6 7 8}

Who Is on the Research Team?

Tulio Valdez, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either male or female.

I am scheduled for surgery on my head or neck that involves opening the area.

Exclusion Criteria

Pregnancy

I have a history of kidney problems.

I am unable or unwilling to follow the study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Participants undergo parotid surgery with fluorescein sodium administered intravenously for nerve visualization

Intraoperative

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fluorescein Sodium

Trial Overview 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.

How Is the Trial Designed?

Group I: Fluorescein sodium during surgery Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The novel near-infrared (NIR) nerve-specific fluorophore, LGW01-08, significantly enhances nerve identification during surgery, allowing for the visualization of nerves buried under approximately 3 mm of tissue, which traditional white light imaging cannot achieve.

In laparoscopic swine surgeries using the da Vinci surgical robot, LGW01-08 demonstrated a favorable safety profile with a 10x difference between toxicity and effective imaging doses, supporting its potential for clinical use in fluorescence guided surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically translatable formulation strategies for systemic administration of nerve-specific probes. Barth, CW., Shah, VM., Wang, LG., et al.[2023]

Sodium fluorescein is a safe and effective fluorescent dye used in neurosurgery, as demonstrated by a case where a patient received a potentially toxic dose (almost 3 g) without any toxic clinical effects during glioma surgery.

Despite challenges in visualization due to intense hyper-fluorescence, the procedure successfully achieved complete tumor resection, reinforcing the dye's utility in distinguishing between tumor and normal brain tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safeness of sodium fluorescein administration in neurosurgery: Case-report of an erroneous very high-dose administration and review of the literature. Restelli, F., Bonomo, G., Monti, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5490159/

Fluorescein sodium-guided surgery of parotid gland tumors ... The use of Fluorescein Sodium in parotidectomy is promising. In two cases residual tumor was detected that would have been left behind under ...

2. nature.com nature.com/articles/s41467-025-60737-x

Intraoperative nerve-specific fluorescence visualization in ... Here, we present data of a nerve imaging agent showing that preoperative intravenous infusion of bevonescein is well tolerated.

3. medrxiv.org medrxiv.org/content/10.1101/2025.02.08.25321923v1.full.pdf

Intraoperative nerve imaging with sodium fluorescein Fluorescence from sodium fluorescein administration improved nerve contrast compared to visible light alone (Figure S7). The results from the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40595556/

Intraoperative nerve-specific fluorescence visualization in ... Here, we present data of a nerve imaging agent showing that preoperative intravenous infusion of bevonescein is well tolerated.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1367593123000996

A review of current intraoperative nerve tissue fluorescence ... This review focuses on the needs and progress in fluorescent probe development for intraoperative nerve tissue identification and visualization.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219357/

Intraoperative nerve-specific fluorescence visualization in ... The authors show in a Phase I multi-site trial that bevonescein was safe, established optimal dosing and timing, and provided a fluorescence signal for ...

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1070878/full

Assessing the role of sodium fluorescein in peripheral ... Fluorescein-guided surgery seems to be a safe and effective technique that can be used during the surgical resection of PNST to identify better and distinguish ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/sstr.202000036

Recent Advances in Intraoperative Nerve Bioimaging ... Intraoperative nerve damage or injury is unavoidable in some surgical procedures and has a significant adverse effect on patients.