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Evaluating Dual Imaging for Head and Neck Cancer

This study is looking at how well two imaging techniques can find head and neck cancer. It uses two substances: panitumumab-IRDye800 and indium In 111 panitumumab. These substances are given through an IV and help doctors see cancer cells better during imaging tests like SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) and during surgery. The main goal is to see if these imaging agents are safe (looking for side effects up to 15 days after treatment). You might be able to join if you are at least 19 years old, have a confirmed diagnosis of head and neck squamous cell carcinoma, and are scheduled for surgery to remove the tumor and lymph nodes. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This study is an interventional trial, meaning participants will receive specific treatments. It plans to enroll 40 participants.
What's involved
You would receive panitumumab-IRDye800 and indium In 111 panitumumab intravenously. You would then undergo SPECT/CT imaging before your planned surgery, which will include fluorescence imaging. You will have a follow-up visit around day 15.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up at day 15 after the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05945875

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer

Recruiting
PHASE1Ages 19+InterventionalDiagnostic
Vanderbilt-Ingram Cancer Center
~40 participants
Updated 2025-10-03 on ClinicalTrials.gov
What's tested:Panitumumab-IRDye800Indium In 111 PanitumumabSingle Photon Emission Computed TomographyComputed TomographyResectionFluorescence Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of grade 2 or higher adverse events
Measured over Up to day 15

Conditions

Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Eben Rosenthal, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center

Who to contact

Nicole Jones
[email protected]
615-936-2807
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>= 19 years
Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed
Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging
Hemoglobin \>= 9 gm/dL
White blood cell count \> 3000/mm\^3
Platelet count \>= 100,000/mm\^3
Serum creatinine =\< 1.5 times upper reference range
Ability to understand and the willingness to sign a written informed consent document

Exclusion

Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
History of infusion reactions to monoclonal antibody therapies
History of allergies to iodine
Pregnant or breastfeeding
Magnesium or potassium lower than the normal institutional values
Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Severe renal disease or anuria
Thyroid stimulating hormone (TSH) \> 13 micro international units/mL

What this trial measures

  • Number of grade 2 or higher adverse eventsUp to day 15

    Will assess the number of grade 2 or higher adverse events determined to be significant and definitely or probably related to the study drugs. Adverse events will be evaluated using the Common Terminology Criteria for Adverse Events version 5.0 and summarized by grade, severity, and type.