Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
| Registry | NCT04351373 |
|---|
| Status | Completed |
|---|
| Phase | Phase 2 |
|---|
| Study type | Interventional; na, single group, masking: none, other |
|---|
| Enrollment | 12 (Actual) |
|---|
| Sponsor | Mayo Clinic (Other) |
|---|
| Conditions | Vestibular Schwannoma |
|---|
| Interventions | Fluorescein Sodium, YELLOW560 filter (Drug, device) |
|---|
| Dates | start 2021-10-06, primary completion 2022-05-25, completion 2022-05-25, first posted 2020-04-17, last updated 2023-08-01 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Vestibular Schwannoma All trials of Fluorescein Sodium All trials of YELLOW560 filter
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery | Experimental | Drug: Fluorescein Sodium; Device: 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 (Drug), also known as AK-Fluor®: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
- YELLOW560 filter (Device), also known as YELLOW 560 nm microscope filter (YE560): Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
+Eligibility
Sex: All, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery |
|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
Outcome results
- Surgeon Predicted Use of Fluorescein Sodium in Future Cases (Primary), Number, participants: Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery 0
- Correlation of Fluorescein Sodium With Surgeons' Visual Assessment (Primary), Number, participants: Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery 1
- Correlation of Fluorescein Sodium With Electrostimulation (Primary), Number, participants: Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery 1
- Time to Differential Visualization (Secondary), Mean, minutes: Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery 41 +/- 24
- Average Dose of Sodium Fluorescein Administration (Secondary), Mean, mg/kg: Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery 3.3 +/- 0.8
- Total Resection Rate (Secondary), Count of participants, Participants: Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery 6
Adverse events
Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately three months on all participants.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery | 0/12 (0.0%) | 0/12 (0.0%) | 1/12 (8.3%) |
Other adverse events by term
| Term | Organ system | Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery |
|---|
| Fever | General disorders | 1/12 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Mayo Clinic in Rochester | Rochester, Minnesota | United States | |
+Publications
- Results publication: 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. PMID 36240730
+Study documents
+Investigators