Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
- Conditions
- Vestibular Schwannoma
- Interventions
- Device: YELLOW560 filter
- Registration Number
- NCT04351373
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery YELLOW560 filter Subjects undergoing clinically planned vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma, removal surgery will have contrast agent fluorescein sodium administered intravenously after tumor exposure, and a special filter called YELLOW560 will be used on the operating microscope to see the fluorescent coloring of the contrast. Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery Fluorescein Sodium Subjects undergoing clinically planned vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma, removal surgery will have contrast agent fluorescein sodium administered intravenously after tumor exposure, and a special filter called YELLOW560 will be used on the operating microscope to see the fluorescent coloring of the contrast.
- Primary Outcome Measures
Name Time Method Surgeon Predicted Use of Fluorescein Sodium in Future Cases Approximately 3 months postoperatively 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.
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment Intraoperatively, approximately 1 day 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.
Correlation of Fluorescein Sodium With Electrostimulation Intraoperatively, approximately 1 day 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.
- Secondary Outcome Measures
Name Time Method Time to Differential Visualization Intraoperatively, approximately 1 day The amount of time in minutes for differential visualization of the tumor and surrounding tissue after sodium fluorescein administration during surgery
Average Dose of Sodium Fluorescein Administration Intraoperatively, approximately 1 day Average dose of sodium fluorescein administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg
Total Resection Rate Intraoperatively, approximately 1 day Number of subjects to have a gross total resection
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States