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| ID | Type | Description | Link |
|---|---|---|---|
| R25DC020174-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescein sodium during surgery | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescein Sodium | Drug | Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation | 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 | Intraoperative (day 1, up to 1 minute to assess) |
| Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve | Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation. | Intraoperative (day 1, up to 1 minute to assess) |
| Ratio of Nerve Fluorescence Compared to Background Tissue | Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity | Intraoperative (Day 1, Up to 20 minutes to assess) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Dose of Sodium Fluorescein Administration | Average dose of sodium fluorescein administered in mg/kg | Intraoperative (day 1) |
| Time to Nerve Visualization | Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tulio Valdez, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40034788 | Result | Park 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluorescein Sodium During Surgery | Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluorescein Sodium During Surgery | Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation | 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 | Posted | Mean | Standard Deviation | score on a scale | Intraoperative (day 1, up to 1 minute to assess) |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluorescein Sodium During Surgery | Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tulio Valdez, MD | Stanford University | 650-724-4800 | tvaldez1@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2024 | Apr 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2024 | Apr 27, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2024 | Apr 20, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000235 | Adenolymphoma |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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Experimental: Fluorescein sodium during surgery
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
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|
| Intraoperative (day 1, up to approximately 200 minutes for initial imaging) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve | Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation. | Posted | Mean | Standard Deviation | score on a scale | Intraoperative (day 1, up to 1 minute to assess) |
|
|
|
| Primary | Ratio of Nerve Fluorescence Compared to Background Tissue | Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity | Posted | Mean | Standard Deviation | Ratio | Intraoperative (Day 1, Up to 20 minutes to assess) |
|
|
|
| Secondary | Average Dose of Sodium Fluorescein Administration | Average dose of sodium fluorescein administered in mg/kg | Posted | Mean | Standard Deviation | mg/kg | Intraoperative (day 1) |
|
|
|
| Secondary | Time to Nerve Visualization | Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration | Posted | Mean | Standard Deviation | minutes | Intraoperative (day 1, up to approximately 200 minutes for initial imaging) |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |