Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Stanford University
Summary
The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).
Description
PRIMARY OBJECTIVE(S): \- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions SECONDARY OBJECTIVE(S): \- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions
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 standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions. * Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results: * Hemoglobin ≥ 9gm/dL * White blood cell count \> 3000/mm3 * Platelet count ≥ 100,000/mm3…
Interventions
- Drug89Zr-panitumumab IV
Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions
- DrugPanitumumab
Panitumumab 30mg will be given orally
Location
- Stanford Cancer InstituteSan Francisco, California