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

Phase I Open-Label 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:

1. Age ≥ 18 years.
2. 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.
3. 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:

1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
2. Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
3. History of infusion reactions to monoclonal antibody therapies.
4. History of allergies to iodine.
5. Pregnant or breastfeeding.
6. Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
7. Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Severe renal disease or anuria.

IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.

Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.

Not reported.