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Completed

NCT Number: NCT04351373

Microscopic Fluorescence-guided Vestibular 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorescein sodium

Drug

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

Other names: AK-Fluor®

YELLOW560 filter

Device

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

Other names: YELLOW 560 nm microscope filter (YE560)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Time to Differential Visualization

    Time frame: 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

  2. Average Dose of Sodium Fluorescein Administration

    Time frame: 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

  3. Total Resection Rate

    Time frame: Intraoperatively, approximately 1 day

    Number of subjects to have a gross total resection

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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