Trial Outcomes & Findings for Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560 (NCT NCT04351373)
NCT ID: NCT04351373
Last Updated: 2023-08-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Approximately 3 months postoperatively
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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Overall Study
Intraoperative diagnosis of facial nerve schwannoma
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1
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Baseline Characteristics
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Baseline characteristics by cohort
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=12 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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Age, Continuous
|
48 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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12 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Approximately 3 months postoperativelyPhysician 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.
Outcome measures
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=8 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Unsure
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0 participants
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Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Plan to not use in any cases
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0 participants
|
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Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Plan to use in select cases
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4 participants
|
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Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Plan to use in the majority of cases
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3 participants
|
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Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Plan to use in all cases
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1 participants
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PRIMARY outcome
Timeframe: Intraoperatively, approximately 1 dayFluorescence 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.
Outcome measures
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=8 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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Correlation of Fluorescein Sodium With Surgeons' Visual Assessment
No correlation
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1 participants
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Correlation of Fluorescein Sodium With Surgeons' Visual Assessment
Some correlation
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0 participants
|
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Correlation of Fluorescein Sodium With Surgeons' Visual Assessment
Good correlation
|
1 participants
|
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Correlation of Fluorescein Sodium With Surgeons' Visual Assessment
Excellent correlation
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6 participants
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PRIMARY outcome
Timeframe: Intraoperatively, approximately 1 daySurgeons' 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.
Outcome measures
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=8 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
|
|---|---|
|
Correlation of Fluorescein Sodium With Electrostimulation
No correlation
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1 participants
|
|
Correlation of Fluorescein Sodium With Electrostimulation
Some correlation
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0 participants
|
|
Correlation of Fluorescein Sodium With Electrostimulation
Good correlation
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3 participants
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Correlation of Fluorescein Sodium With Electrostimulation
Excellent correlation
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4 participants
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SECONDARY outcome
Timeframe: Intraoperatively, approximately 1 dayThe amount of time in minutes for differential visualization of the tumor and surrounding tissue after sodium fluorescein administration during surgery
Outcome measures
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=11 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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Time to Differential Visualization
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41 minutes
Standard Deviation 24
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SECONDARY outcome
Timeframe: Intraoperatively, approximately 1 dayAverage dose of sodium fluorescein administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg
Outcome measures
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=11 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
|
|---|---|
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Average Dose of Sodium Fluorescein Administration
|
3.3 mg/kg
Standard Deviation 0.8
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SECONDARY outcome
Timeframe: Intraoperatively, approximately 1 dayNumber of subjects to have a gross total resection
Outcome measures
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=11 Participants
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
|
|---|---|
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Total Resection Rate
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6 Participants
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Adverse Events
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery
n=12 participants at risk
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: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
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|---|---|
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General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately three months on all participants.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place