Vestibular SchwannomaPhase 2NCT04351373
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
A Phase 2 study testing Fluorescein Sodium and YELLOW560 filter in people with Vestibular Schwannoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- Fluorescein Sodium and YELLOW560 filter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 25 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a suspected VS
- Recurrent VS with prior microsurgical resection or radiation therapy
- Clinical indication for microsurgical resection
Who cannot join
- History of allergy to FS
- History of renal failure
- Pregnant women
- Those with inability to give informed consent
- Prisoners and inmates
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
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.
- Conditions
- Vestibular Schwannoma
- Being tested
- Fluorescein Sodium, YELLOW560 filter
- Keywords
- Head and Neck Paraganglioma, Head and Neck Schwannoma
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein SodiumDrug
Also called AK-Fluor®
Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filterDevice
Also called YELLOW 560 nm microscope filter (YE560)
Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery | Experimental | 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. Receives: Drug: Fluorescein Sodium; Device: YELLOW560 filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 months postoperatively
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.
Measured: Intraoperatively, approximately 1 day
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.
Measured: Intraoperatively, approximately 1 day
Secondary outcomes (3)
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
Measured: Intraoperatively, approximately 1 day
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
Measured: Intraoperatively, approximately 1 day
Total Resection Rate
Number of subjects to have a gross total resection
Measured: Intraoperatively, approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start6 Oct 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew L. Carlson, M.D., Mayo Clinic
- Investigators
- Matthew L Carlson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351373
- Sponsor's protocol ID
- 19-005178
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36240730
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
- ClinicalTrials.gov ID
- NCT04351373
- Acronym / sponsor ID
- 19-005178
- Conditions
- Vestibular Schwannoma
- Keywords
- Head and Neck Paraganglioma, Head and Neck Schwannoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery | Experimental | Drug: Fluorescein Sodium, Device: YELLOW560 filterSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with a suspected VS
- Recurrent VS with prior microsurgical resection or radiation therapy
- Clinical indication for microsurgical resection
Key exclusion criteria (5 listed)
- History of allergy to FS
- History of renal failure
- Pregnant women
- Those with inability to give informed consent
- Prisoners and inmates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescein SodiumAlso: AK-Fluor®Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered. | Drug | Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery |
| YELLOW560 filterAlso: YELLOW 560 nm microscope filter (YE560)Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection. | Device | Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery |
Primary outcome
Surgeon Predicted Use of Fluorescein Sodium in Future Cases
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Time to Differential Visualization
Time frame: Intraoperatively, approximately 1 day
Average Dose of Sodium Fluorescein Administration
Time frame: Intraoperatively, approximately 1 day
Total Resection Rate
Time frame: Intraoperatively, approximately 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36240730Chan 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew L Carlson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorescein Sodium and YELLOW560 filter in people with Vestibular Schwannoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Predicted Use of Fluorescein Sodium in Future Cases (time frame: Approximately 3 months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.