Vestibular Schwannoma
Conditions
Keywords
Head and Neck Paraganglioma, Head and Neck Schwannoma
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.
Interventions
Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
DEVICEYELLOW560 filter
Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Intraoperative diagnosis of facial nerve schwannoma | 1 |
Baseline characteristics
| Characteristic | Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery |
|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 15.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Intraoperatively, approximately 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Electrostimulation | No correlation | 1 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Electrostimulation | Some correlation | 0 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Electrostimulation | Good correlation | 3 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Electrostimulation | Excellent correlation | 4 participants |
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.
Time frame: Intraoperatively, approximately 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Surgeons' Visual Assessment | No correlation | 1 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Surgeons' Visual Assessment | Some correlation | 0 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Surgeons' Visual Assessment | Good correlation | 1 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Correlation of Fluorescein Sodium With Surgeons' Visual Assessment | Excellent correlation | 6 participants |
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.
Time frame: Approximately 3 months postoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Surgeon Predicted Use of Fluorescein Sodium in Future Cases | Unsure | 0 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Surgeon Predicted Use of Fluorescein Sodium in Future Cases | Plan to not use in any cases | 0 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Surgeon Predicted Use of Fluorescein Sodium in Future Cases | Plan to use in select cases | 4 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Surgeon Predicted Use of Fluorescein Sodium in Future Cases | Plan to use in the majority of cases | 3 participants |
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Surgeon Predicted Use of Fluorescein Sodium in Future Cases | Plan to use in all cases | 1 participants |
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
Time frame: Intraoperatively, approximately 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Average Dose of Sodium Fluorescein Administration | 3.3 mg/kg | Standard Deviation 0.8 |
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
Time frame: Intraoperatively, approximately 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Time to Differential Visualization | 41 minutes | Standard Deviation 24 |
Secondary
Total Resection Rate
Number of subjects to have a gross total resection
Time frame: Intraoperatively, approximately 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | Total Resection Rate | 6 Participants |