Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
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).
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
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:
Exclusion Criteria: