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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2022-05-25

Brief Summary

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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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Detailed Description

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Conditions

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Vestibular Schwannoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Fluorescein Sodium

Intervention Type DRUG

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

YELLOW560 filter

Intervention Type DEVICE

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

Interventions

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Fluorescein Sodium

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

Intervention Type DRUG

YELLOW560 filter

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

Intervention Type DEVICE

Other Intervention Names

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AK-Fluor® YELLOW 560 nm microscope filter (YE560)

Eligibility Criteria

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Inclusion Criteria

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