This phase II trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03405142.
PRIMARY OBJECTIVE:
I. To determine if near-infrared fluorescence imaging of panitumumab-IRDye800 can identify metastatic disease in regional neck lymph nodes of subjects with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVE:
I. Determine if panitumumab-IRDye800 can identify sentinel nodes with the same accuracy as technetium Tc 99m-labeled tilmanocept (Lymphoseek).
OUTLINE:
Beginning 1-5 days before surgery, patients receive panitumumab IRDye800 intravenously (IV) over 15 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled tilmanocept via injection and undergo lymphoscintigraphy and single photon emission computed tomography/computed tomography (SPECT/CT).
After completion of study, patients are followed up for 30 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorFred Baik
