Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Eben Rosenthal
Summary
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 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).
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 inva…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
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 or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal * Hemoglobin \>= 9gm/dL * White blood cell count \> 3000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Serum creatinine =\< 1.5 times upper refer…
Interventions
- BiologicalPanitumumab
Given IV
- DrugZirconium Zr 89 Panitumumab
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
- ProcedureComputed Tomography
Undergo PET/CT
- OtherElectronic Health Record Review
Ancillary studies
Location
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee