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Glow-in-the-Dark dye could help surgeons spot hidden oral cancer cells

NCT ID NCT05316688

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tested a dye called tozuleristide that makes oral cancer cells glow under special light during surgery. The goal was to help surgeons see and remove all cancer while sparing healthy tissue. The trial included 8 adults with oral cavity cancer or high-grade dysplasia. The study was terminated early, so results are limited.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

8 people

The number who actually took part.

Started

Apr 2024

Finished

Sep 2025

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.

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: * Adult subjects age \>= 18 years (yr) * Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery * Able to provide written informed consent * If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential * Available for all study visits and able to comply with all study requirements Exclusion Criteria: * Known or suspected sensitivity to indocyanine green * In the opinion of the treating physician, subject has received photosensitizing medication that could interfere or confound study results * Any current medications with the potential to generate fluorescence or photochemical reaction * Enrolled in any other ongoing study * Currently lactating or breastfeeding * Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide * Any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data * Creatinine clearance \< 60 mL/min * Aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) \> 1.5 x ULN * Bilirubin \> 1.5 x ULN

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Conditions

The condition(s) this trial relates to.

intraepithelial neoplasia lip and oral cavity carcinoma lip and oral cavity squamous cell carcinoma Mouth Neoplasms oral cavity 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.

Oral cavity squamous cell carcinoma Stage I lip and oral cavity cancer ajcc V8 Stage II lip and oral cavity cancer ajcc V8 Stage III lip and oral cavity cancer ajcc V8 Stage IVA lip and oral cavity cancer ajcc V8

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.