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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Fluorescein Sodium for nerve identification in head and neck surgery?

Research shows that sodium fluorescein helps in identifying cranial nerves during surgery for skull base meningiomas by providing clear contrast, which aids in preserving these nerves. This suggests it could be useful in head and neck surgeries for better nerve identification. ^{1 2 3 4 5}

Is sodium fluorescein generally safe for use in humans?

Sodium fluorescein is generally considered safe for use in humans, with few reports of severe complications. It has been widely used in neurosurgery for brain tumors and vascular issues, and is well tolerated, although further study is needed to fully understand its safety profile. ^{1 2 6 7 8}

How does the drug Fluorescein Sodium differ from other treatments for nerve identification in head and neck surgery?

Fluorescein Sodium is unique because it enhances the contrast between nerves and surrounding tissues, making it easier for surgeons to identify and preserve nerves during surgery. This is particularly useful in complex surgeries where nerve identification is challenging, and it offers a visual aid that is not typically available with standard surgical techniques. ^{1 2 9 10 11}

What is the purpose of this trial?

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.

Research Team

Tulio Valdez, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Skull Base Meningiomas and Cranial Nerves Contrast Using Sodium Fluorescein: A New Application of an Old Tool. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Sodium Fluorescein as Intraoperative Visualization Tool During Peripheral Nerve Biopsies. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Clinically translatable formulation strategies for systemic administration of nerve-specific probes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In vivo nerve identification in head and neck surgery using diffuse reflectance spectroscopy. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the role of sodium fluorescein in peripheral nerve sheath tumors and mimicking lesions surgery: An update after 142 cases. [2023]

6. Netherlands 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. [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Fluorescein fluorescence use in the management of intracranial neoplastic and vascular lesions: a review and report of a new technique. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Sodium fluorescein in pediatric oncological neurosurgery: a pilot study on 50 children. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Simple Improvisation to Enhance Utility of Fluorescein Sodium in Resection of Intracranial Lesions at Routine Neurosurgical Centers. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

A new method for using fluorescein to demonstrate oto- and rhinoliquorrhea. I. Sample preparation by electrophoresis and photometric identification of fluorescein. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Fluorescein sodium-guided surgery of parotid gland tumors as a technical advance. [2020]