At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
Fluorescein Sodium +1 moredrug
Likely dose
Fluorescein Sodium 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
In Brief
A Phase 2 clinical trial evaluating Fluorescein Sodium and YELLOW560 filter for Vestibular Schwannoma. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVestibular Schwannoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartOct 2021
Primary CompletionMay 2022
TodayJul 2026
First PostedApr 17, 2020
Enrollment StartOct 6, 2021
Primary CompletionMay 25, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.2 years ago
Interventions
Fluorescein Sodiumdrug
Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.
YELLOW560 filterdevice
Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.