Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma

Inclusion criteria

• Age ≥ 18 years.
• Subjects diagnosed with any T stage or N stage squamous cell carcinoma and 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.
• Have acceptable hematologic status, kidney function, and liver function including the following clinical results:

• Hemoglobin ≥ 9 gm/dL
• White blood cell count > 3000/mm3
• Platelet count ≥ 100,000/mm3
• Serum creatinine ≤ 1.5 times upper reference range
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• 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 QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
• History of infusion reactions to monoclonal antibody therapies.
• History of allergies to iodine.
• Pregnant or breastfeeding.
• Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
• Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
• Severe renal disease or anuria.