Clinical trial · Interventional
Identification of Nerves Using Fluorescein Sodium
Intraoperative Nerve Identification With Fluorescein Sodium
NCT06054178CI-TRIAL-00112162completedPhase 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 in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck | — | UNRESOLVED | — |
| Head and Neck Disorder | — | UNRESOLVED | — |
| Pleomorphic Adenoma of the Parotid | Parotid Gland Pleomorphic Adenoma | ALIAS | 0.90 |
| Thyroid Disease | — | UNRESOLVED | — |
| Thyroidectomy | — | UNRESOLVED | — |
| Warthin Tumor | Warthin Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescein Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorescein sodium during surgery
- description
- Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively
- interventionNames
- Drug: Fluorescein Sodium
Primary outcomes (3)
- measure
- Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation
- timeFrame
- Intraoperative (day 1, up to 1 minute to assess)
- description
- Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation
- measure
- Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female subjects 2. 18 years or older 3. Scheduled for open head and neck surgery Exclusion Criteria: 1. Inability or unwillingness of a subject 2. Pregnancy 3. Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students) 4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study 5. History of adverse reaction to fluorescein including allergy. 6. History of renal failure or chronic kidney disease
References
Publications (1)
- RESULTPark RK, Arus BA, Lee JY, Weitzenberg MM, Lee MC, Nyaeme MS, Barthel J, Balsamo G, Baik FM, Speirs K, Blume B, Heller-Algazi M, Chmyrov A, Plettenburg O, Megwalu UC, Weitz J, Distler M, Bruns OT, Valdez TA. Intraoperative nerve imaging with sodium fluorescein. medRxiv [Preprint]. 2025 Feb 17:2025.02.08.25321923. doi: 10.1101/2025.02.08.25321923. PMID 40034788