Neoplasms

All Conditions

Nervous System Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Paraganglioma

Neurilemmoma

Meningioma

Neuroma, Acoustic

Neuroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Cranial Nerve Diseases

Paragangliomas 1

Schwannoma

Acoustic Neuroma

Neuroendocrine Tumor

Neuroepithelioma

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.

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

Fluorescein Sodium

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

YELLOW560 filter

Matthew L Carlson, MD

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.

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

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

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.

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.

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.

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 administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg

Number of subjects to have a gross total resection

Mayo Clinic

Principal Investigator

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.

Spots Global Cancer Trial Database for Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial