Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Primary Purpose
Vestibular Schwannoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluorescein Sodium
YELLOW560 filter
Sponsored by
About this trial
This is an interventional other trial for Vestibular Schwannoma focused on measuring Head and Neck Paraganglioma, Head and Neck Schwannoma
Eligibility Criteria
Inclusion Criteria
- Patient with a suspected VS
- Recurrent VS with prior microsurgical resection or radiation therapy
- Clinical indication for microsurgical resection
Exclusion Criteria
- Children (patients less than 18 years of age)
- History of allergy to FS
- History of renal failure
- Pregnant women
- Those with inability to give informed consent
- Prisoners and inmates
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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
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
Total Resection Rate
Number of subjects to have a gross total resection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04351373
Brief Title
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Official Title
Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
Head and Neck Paraganglioma, Head and Neck Schwannoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluorescein Sodium
Other Intervention Name(s)
AK-Fluor®
Intervention Description
Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
Intervention Type
Device
Intervention Name(s)
YELLOW560 filter
Other Intervention Name(s)
YELLOW 560 nm microscope filter (YE560)
Intervention Description
Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
Primary Outcome Measure Information:
Title
Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Description
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.
Time Frame
Approximately 3 months postoperatively
Title
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment
Description
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.
Time Frame
Intraoperatively, approximately 1 day
Title
Correlation of Fluorescein Sodium With Electrostimulation
Description
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.
Time Frame
Intraoperatively, approximately 1 day
Secondary Outcome Measure Information:
Title
Time to Differential Visualization
Description
The amount of time in minutes for differential visualization of the tumor and surrounding tissue after sodium fluorescein administration during surgery
Time Frame
Intraoperatively, approximately 1 day
Title
Average Dose of Sodium Fluorescein Administration
Description
Average dose of sodium fluorescein administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg
Time Frame
Intraoperatively, approximately 1 day
Title
Total Resection Rate
Description
Number of subjects to have a gross total resection
Time Frame
Intraoperatively, approximately 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew L Carlson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36240730
Citation
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):1240-1244. doi: 10.1097/MAO.0000000000003718. Epub 2022 Oct 14.
Results Reference
result
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
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