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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Vestibular Schwannoma

Treatments: Drug: Fluorescein Sodium; Device: YELLOW560 filter

Study type: Interventional

Funder types: Other

Identifiers

NCT04351373

19-005178

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: YELLOW560 filter

Drug: Fluorescein Sodium