Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ENT0095 | Other Identifier | Stanford OnCore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| panitumumab 30 mg | Active Comparator | Subjects will be given a 30mg of panitumumab |
|
| 89Zr-panitumumab IV | Experimental | Subjects will be given 89Zr-panitumumab IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-panitumumab IV | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of 89Zr-panitumumab | 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging | 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roan C Raymundo, BS | Contact | (650) 721-4071 | rcraymun@stanford.edu | |
| Grace Yi | Contact | 650-723-1423 | gracesyi@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fred Baik, MD | Stanford Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | San Francisco | California | 94305 | United States |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Panitumumab | Drug | Panitumumab 30mg will be given orally |
|
| Up to 1 year |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |