Head-and-neck Squamous Cell Carcinoma
Conditions
Brief 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).
Detailed 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
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
Sponsors
Andrei Iagaru
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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 * Serum creatinine ≤ 1.5 times upper reference range * PTT = 11.5 - 14.4 seconds * INR = 0.9 - 1.2
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of 89Zr-panitumumab | Up to 1 year | The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging | Up to 1 year | The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 18F-FDG using PET/CT imaging. The specificity and sensitivity of 89Zr-panitumumab will be compared to the specificity and sensitivity of 18F-FDG for identification of metastatic lesions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFred Baik, MD
Stanford Cancer Institute
Outcome results
None listed