Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Vestibular Schwannoma Clinical Trial

Official title:

Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351373
• Other study ID #: 19-005178
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if there is benefit to using an IV contrast called AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patient with a suspected VS
• Recurrent VS with prior microsurgical resection or radiation therapy
• Clinical indication for microsurgical resection Exclusion Criteria
• History of allergy to FS
• History of renal failure
• Pregnant women
• Those with inability to give informed consent
• Prisoners and inmates

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Drug:
• Fluorescein Sodium
Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.

Device:
• YELLOW560 filter
Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chan SA, Macielak RJ, Tuchscherer AM, Neff BA, Driscoll CLW, Peris-Celda M, Van Gompel JJ, Link MJ, Carlson ML. Fluorescein-Assisted Microsurgical Resection of Vestibular Schwannoma: A Prospective Feasibility Study. Otol Neurotol. 2022 Dec 1;43(10):1240-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon Predicted Use of Fluorescein Sodium in Future Cases	Physician response to surgeon survey question, "Based on the use and performance of FS in this case alone, how likely are you to use FS in future cases (excluding the research trial) involving this tumor?" using a Likert-style rating from 0-4 where 0=Unsure; 1= Plan to not use in any cases; 2= Plan to use in select cases; 3=Plan to use in the majority of cases; 4=Plan to use in all cases.	Approximately 3 months postoperatively
Primary	Correlation of Fluorescein Sodium With Surgeons' Visual Assessment	Fluorescence correlate with surgeons' visual assessment of the tumor and nerve tissue under normal microscopy without the Yellow 560 filter using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.	Intraoperatively, approximately 1 day
Primary	Correlation of Fluorescein Sodium With Electrostimulation	Surgeons' assessment of fluorescence correlate with electrostimulation (e.g. tissues with high fluorescence do not stimulate, whereas nerve tissues with low fluorescence do stimulate)" using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.	Intraoperatively, approximately 1 day
Secondary	Time to Differential Visualization	The amount of time in minutes for differential visualization of the tumor and surrounding tissue after sodium fluorescein administration during surgery	Intraoperatively, approximately 1 day
Secondary	Average Dose of Sodium Fluorescein Administration	Average dose of sodium fluorescein administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg	Intraoperatively, approximately 1 day
Secondary	Total Resection Rate	Number of subjects to have a gross total resection	Intraoperatively, approximately 1 day

External Links

•   Mayo Clinic Clinical Trials