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Glow-in-the-Dark dye helps surgeons spot hidden cancer

NCT ID NCT04511078

Diagnosis Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a dye called panitumumab-IRDye800 can make head and neck cancer cells glow during surgery, helping surgeons see and remove all cancer while sparing healthy tissue. About 25 adults with head and neck cancer scheduled for surgery will receive the dye before their operation. The goal is to see if the dye clearly highlights cancer compared to normal tissue and to check its safety.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

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

Started

Apr 2021

Expected to finish

Dec 2030

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.

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: 1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck 2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed. 3. Planned standard of care surgery with curative intent for squamous cell carcinoma 4. Male or female patients age ≥ 18 years 5. Have life expectancy of more than 12 weeks 6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1 7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin ≥ 9 gm/dL 2. Absolute Neutrophil Count ≥ 1500 3. White Blood Cell count \> 3000/mm3 4. Platelet count ≥ 100,000/mm3 5. Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: 1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800 2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF 3. History of infusion reactions to any monoclonal antibody therapies 4. Women who are pregnant or breast-feeding 5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) 6. Magnesium or potassium lower than the normal institutional values 7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents 8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis 9. TSH \> 13 micro International Units/mL

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

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

Head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

More trials for these conditions

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