Clinical trial · Interventional
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
NCT04351373CI-TRIAL-00068414completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescein Sodium | Drug | — | UNRESOLVED |
| YELLOW560 filter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery
- 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.
- interventionNames
- Drug: Fluorescein Sodium
- Device: YELLOW560 filter
Primary outcomes (3)
- measure
- Surgeon Predicted Use of Fluorescein Sodium in Future Cases
- timeFrame
- Approximately 3 months postoperatively
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChan SA, Macielak RJ, Tuchscherer AM, Neff BA, Driscoll CLW, Peris-Celda M, Van Gompel JJ, Link MJ, Carlson ML. Fluorescein-Assisted Microsurgical Resection of Vestibular Schwannoma: A Prospective Feasibility Study. Otol Neurotol. 2022 Dec 1;43(10):1240-1244. doi: 10.1097/MAO.0000000000003718. Epub 2022 Oct 14. PMID 36240730