(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).

Detailed Description
-----------------
PRIMARY OBJECTIVE: - Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zrpanitumumab) for the detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma. SECONDARY OBJECTIVE: - Compare sensitivity and specificity of standard of care imaging modalities (magnetic resonance imaging [MRI], CT and/or fludeoxyglucose F-18 [18F]-PET/CT) to 89Zr-panitumumab-PET/CT for detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma. EXPLORATORY OBJECTIVE: - Determine rate of intervention (e.g., biopsy or other invasive procedures) versus (vs) non-intervention (e.g., serial imaging, observation) by treatment team in subjects with indeterminate metastatic lesions on standard of care imaging. OUTLINE: Patients receive panitumumab intravenously (IV), 89Zr panitumumab IV, and undergo PET/CT on study.

Official Title
-----------------
Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
-----------------
* Biological: Panitumumab
* Drug: Zirconium Zr 89 Panitumumab
* Procedure: Positron Emission Tomography
* Procedure: Computed Tomography
* Other: Electronic Health Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Subjects with recurrent disease or a new primary will be allowed Must have evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT Hemoglobin >= 9gm/dL White blood cell count > 3000/mm^3 Platelet count >= 100,000/mm^3 Serum creatinine =< 1.5 times upper reference range Estimated glomerular filtration rate (eGFR) >= 60mL/min/1.73m^2 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 History of infusion reactions to other monoclonal antibody therapies Pregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), 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 Known hypersensitivity to deferoxamine or any of its components

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (89Zr panitumumab PET/CT)<br>Patients receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study | Biological: Panitumumab<br>* Given IV<br>Drug: Zirconium Zr 89 Panitumumab<br>* Given IV<br>Procedure: Positron Emission Tomography<br>* Undergo PET/CT<br>Procedure: Computed Tomography<br>* Undergo PET/CT<br>Other: Electronic Health Record Review<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab | The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using positron emission tomography (PET)/computed tomography (CT) imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates. | Up to 7 years | 
| Specificity of 89Zr-panitumumab | The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using PET/CT imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates. | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 89Zr-panitumumab | The sensitivity of 89Zr-panitumumab will be compared to the sensitivity of standard of care imaging modalities, including magnetic resonance imaging (MRI), CT, and/or fludeoxyglucose F-18 (18F-FDG) PET/CT. Will use the matched pair Durkalski's test, accounting for the cluster-correlation within subjects, for the sensitivity comparisons. | Up to 7 years | 
| Specificity of 89Zr-panitumumab | The specificity of 89Zr-panitumumab will be compared to the specificity of standard of care imaging modalities, including MRI, CT, and/or 18F-FDG PET/CT. Will use the matched pair Durkalski's test, accounting for the cluster-correlation within subjects, for the specificity comparisons. | Up to 7 years |