Pleomorphic Adenoma of the ParotidPhase 2NCT06054178
Identification of Nerves Using Fluorescein Sodium
A Phase 2 study testing Fluorescein Sodium in people with Pleomorphic Adenoma of the Parotid and Warthin Tumor, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder
- What is being tested?
- Fluorescein Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to 22 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects
- 18 years or older
- Scheduled for open head and neck surgery
Who cannot join
- Inability or unwillingness of a subject
- Pregnancy
- Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- History of adverse reaction to fluorescein including allergy.
- History of renal failure or chronic kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Medical Center
Palo Alto, California, 94304
About this study
Official title: Intraoperative Nerve Identification With Fluorescein Sodium
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
- Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder, Head and Neck, Thyroid Disease, Thyroidectomy
- Being tested
- Fluorescein Sodium
- Medical subject headings
- Adenolymphoma, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein SodiumDrug
Also called FLUORESCITE Injection 10%
Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fluorescein Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: Intraoperative (Day 1, Up to 20 minutes to assess)
Secondary outcomes (2)
Average Dose of Sodium Fluorescein Administration
Average dose of sodium fluorescein administered in mg/kg
Measured: Intraoperative (day 1)
Time to Nerve Visualization
Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration
Measured: Intraoperative (day 1, up to approximately 200 minutes for initial imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 Nov 2024
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleomorphic Adenoma of the ParotidStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Tulio Valdez, Stanford University
- Investigators
- Tulio Valdez, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054178
- Sponsor's protocol ID
- 71857
- Other IDs
- R25DC020174-03
- Status last verified
- Jul 2025
- First submitted
- 19 Sep 2023
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40034788
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Nerve Identification With Fluorescein Sodium
- ClinicalTrials.gov ID
- NCT06054178
- Acronym / sponsor ID
- 71857
- Conditions
- Pleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder, Head and Neck, Thyroid Disease, Thyroidectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Fluorescein sodium during surgery | Experimental | Drug: Fluorescein SodiumSubjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects
- 18 years or older
- Scheduled for open head and neck surgery
Key exclusion criteria (6 listed)
- Inability or unwillingness of a subject
- Pregnancy
- Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- History of adverse reaction to fluorescein including allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescein SodiumAlso: FLUORESCITE Injection 10%Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg | Drug | Fluorescein sodium during surgery |
Primary outcome
Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation
Time frame: Intraoperative (day 1, up to 1 minute to assess)
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
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve
Time frame: Intraoperative (day 1, up to 1 minute to assess)
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.
Ratio of Nerve Fluorescence Compared to Background Tissue
Time frame: Intraoperative (Day 1, Up to 20 minutes to assess)
Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity
2 secondary outcomes
Average Dose of Sodium Fluorescein Administration
Time frame: Intraoperative (day 1)
Time to Nerve Visualization
Time frame: Intraoperative (day 1, up to approximately 200 minutes for initial imaging)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40034788Park 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tulio Valdez, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorescein Sodium in people with Pleomorphic Adenoma of the Parotid and Warthin Tumor, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation (time frame: Intraoperative (day 1, up to 1 minute to assess)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.