Glow-in-the-Dark dye could help surgeons spot hidden cancer
NCT ID NCT06819228
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times
Summary
This early-phase trial tests a fluorescent dye attached to the cancer drug panitumumab to help surgeons see head and neck cancer during surgery. 18 adults with head and neck squamous cell carcinoma will receive the dye before surgery, and a special camera will highlight cancer tissue. The goal is to find the best dose for imaging and to improve tumor removal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Panitumumab-IRDye800 (a fluorescently labeled version of the drug panitumumab)
- What this could lead to
- If successful, this approach could help surgeons remove more cancer tissue during surgery and find the right drug dose for future treatments.
- What could go wrong
- This is a very early, small study (18 people) focused on imaging and dosing, not treatment effectiveness. The dye is investigational and may not improve outcomes.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Willing to review and sign written informed consent. * Male or female patients age \> 18 years. * Tissue confirmation of head and neck squamous cell carcinoma. * Patients for whom a potentially curative resection is planned as standard of care. * ECOG performance status of 0 or 1 * Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age). * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below: • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and/or both ovaries and/or both fallopian tubes). Post-menarchal is defined as either: * age \>55 years old * age \<55 years or less and * at least 12 months since last menstrual period, * at least 6 months since last menstrual period and FSH \> 40 IU * Women of childbearing potential must have a negative pregnancy test result within 14 days prior to initiation of study treatment. * Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab. * Men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab/pan800 to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period. Exclusion Criteria: * Patients not eligible for standard of care surgical resection * Patients with a history of infusion reactions or allergic reactions to panitumumab. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. • History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial. * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. * Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial. * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment. * Magnesium or phosphorus lower than normal institutional values, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies. * Evidence of QTcF prolongation on pretreatment ECG.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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