This phase I trial studies the side effects of 111In-panitumumab for nodal staging of head of neck cancer. Often cancerous cells have unusual proteins on their surface. One way of tracking down cancerous cells is to use a 'monoclonal' antibody that latches onto these unusual proteins. 111In-panitumumab is a monoclonal antibody, panitumumab, linked to a radioactive element 111In (indium). Panitumumab will latch onto the proteins on the surface of the cancer and with the help of the linked radioactive indium, doctors may be able to more easily find lymph nodes that have cancerous cells before and during surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04840472.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Temporarily closed to accrual
Contact: Fred Baik
Phone: 650-498-6000
PRIMARY OBJECTIVE:
I. Assess the safety of 111In-panitumumab as a molecular imaging agent in patients with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVE:
I. Compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In panitumumab prior to day of surgery versus conventional local injection with an optical dye at the time of surgery.
EXPLORATORY OBJECTIVES:
I. Dosimetry.
II. Determine if systemic injection of 111In-panitumumab can identify tumor-positive lymph nodes on preoperative single photon emission computed tomography (SPECT)/computed tomography (CT).
III. When preoperative imaging information (e.g., fludeoxyglucose F-18 [18F FDG] positron emission tomography [PET]/CT and/or magnetic resonance imaging [MRI]) data is available:
IIIa. Evaluate the sensitivity, specificity and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity and negative predictive value of preoperative MRI in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).
IIIb. Evaluate the sensitivity, specificity and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity and negative predictive value of preoperative 18F FDG PET/CT in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).
OUTLINE:
Patients receive panitumumab intravenously (IV) over 15 minutes and 111In-panitumumab IV on day 0, and undergo SPECT/CT over 20 minutes once between day 1 and the day of surgery. Patients then undergo surgical resection per standard of care.
After completion of study intervention, patients are followed up for 15 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorFred Baik
