Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

NCT04351373 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 19-005178
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

Head and Neck Paraganglioma; Head and Neck Schwannoma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Intraoperatively, approximately 1 day

Secondary Outcomes (3)

• Time to Differential Visualization

  Intraoperatively, approximately 1 day

• Average Dose of Sodium Fluorescein Administration

  Intraoperatively, approximately 1 day

• Total Resection Rate

  Intraoperatively, approximately 1 day

Study Arms (1)

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.

Drug: Fluorescein Sodium; Device: YELLOW560 filter

Interventions

Fluorescein Sodium DRUG

Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.

Also known as: AK-Fluor®

Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery

YELLOW560 filter DEVICE

Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.

Also known as: YELLOW 560 nm microscope filter (YE560)

Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a suspected VS
• Recurrent VS with prior microsurgical resection or radiation therapy
• Clinical indication for microsurgical resection

You may not qualify if:

• History of allergy to FS
• History of renal failure
• Pregnant women
• Those with inability to give informed consent
• Prisoners and inmates

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Fluorescein; Fluoresceins

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Matthew Carlson
• Organization: Mayo Clinic

Carlson.Matthew@mayo.edu

507-284-8532

Study Officials

• Matthew L Carlson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 17, 2020
• Study Start: October 6, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)