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Can a glowing dye show surgeons where head and neck tumors end?

NCT ID NCT07825597

Diagnosis Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers at Washington University School of Medicine are studying whether a fluorescent dye called indocyanine green can help visualize the edges of head and neck squamous cell carcinoma during surgery. The study plans to enroll 25 adults who are having surgery for confirmed or strongly suspected cancer. Participants receive the dye as part of their routine care, and researchers record near-infrared images during the operation, then compare the fluorescence patterns with tissue biopsy results. The imaging does not guide surgical decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
indocyanine green, a fluorescent dye given into a vein during surgery
What this could lead to
If the dye lights up tumor tissue reliably, surgeons could one day use it to judge tumor edges during head and neck cancer operations.
What could go wrong
The study is small and observational, and the imaging does not guide surgery. The dye may not separate tumor from normal tissue well enough to be useful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with histologically or cytologically confirmed, or strong clinical suspicion of, head and neck squamous cell carcinoma who are preparing to undergo surgical resection at Washington University School of Medicine / Barnes-Jewish Hospital.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed, or strong clinical suspicion contingent on standard of care pre-operative assessment, of head and neck squamous cell carcinoma (HNSCC), preparing to undergo surgical resection. * At least 18 years of age. * The effects of ICG on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to surgery and for 1 week after surgery. Should a woman become pregnant or suspect she is pregnant during this time or should a man suspect he has fathered a child, s/he must inform her treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG, sodium iodide, or other agents used in the study. * Thyroid radioactive uptake study within 1 week of ICG administration. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day of surgery.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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