Evidence from our lab and others has demonstrated the potential of fluorescently labeled antibodies to measure microscopic disease to guide surgical intervention preclinical models. We present novel data demonstrating safety of the fluorescently labeled anti- EGFR antibody in non-human primates. We propose a clinical trial with fluorescently labeled cetuximab to detect subclinical cancer in the operating room existing imaging equipment to guide surgical resection of head and neck cancer. The proposed trial has received IRB and IND approval in September 2013.
Because of the crude techniques surgeons currently use to assess tumors, it is not surprising that tumor margins are positive in 30% of head and neck cancer (HNC) resections. If tumor margins could be accurately assessed intraoperatively, it is possible that less healthy tissue would be removed and survival rates improved. We have previously demonstrated intravenous administration of fluorescently labeled anti-EGFR antibody can image microscopic tumor fragments in multiple preclinical models. Furthermore, we present novel data demonstrating the safety of cetuximab-IRDye800 in non-human primate studies. We plan to administer escalating doses of cetuximab- IRDye800 to determine safety and tumor specificity in humans in the proposed IND and IRB approved study. We propose to perform histopathological review of resected tumors to determine sensitivity and specificity of cetuximab-IRDye800 for subclinical disease.