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.

Public Health Relevance

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.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Exploratory/Developmental Grants (R21)
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Special Emphasis Panel (ZRG1)
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Farahani, Keyvan
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University of Alabama Birmingham
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Gao, Rebecca W; Teraphongphom, Nutte; de Boer, Esther et al. (2018) Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers. Theranostics 8:2488-2495
Gao, Rebecca W; Teraphongphom, Nutte T; van den Berg, Nynke S et al. (2018) Determination of Tumor Margins with Surgical Specimen Mapping Using Near-Infrared Fluorescence. Cancer Res 78:5144-5154
Rosenthal, Eben L; Moore, Lindsay S; Tipirneni, Kiranya et al. (2017) Sensitivity and Specificity of Cetuximab-IRDye800CW to Identify Regional Metastatic Disease in Head and Neck Cancer. Clin Cancer Res 23:4744-4752
Moore, Lindsay S; Rosenthal, Eben L; de Boer, Esther et al. (2017) Effects of an Unlabeled Loading Dose on Tumor-Specific Uptake of a Fluorescently Labeled Antibody for Optical Surgical Navigation. Mol Imaging Biol 19:610-616
Zhang, Ray R; Schroeder, Alexandra B; Grudzinski, Joseph J et al. (2017) Beyond the margins: real-time detection of cancer using targeted fluorophores. Nat Rev Clin Oncol 14:347-364
Warram, Jason M; de Boer, Esther; van Dam, Gooitzen M et al. (2016) Fluorescence imaging to localize head and neck squamous cell carcinoma for enhanced pathological assessment. J Pathol Clin Res 2:104-12
Warram, Jason M; de Boer, Esther; Moore, Lindsay S et al. (2015) A ratiometric threshold for determining presence of cancer during fluorescence-guided surgery. J Surg Oncol 112:2-8
Rosenthal, Eben L; Warram, Jason M; de Boer, Esther et al. (2015) Safety and Tumor Specificity of Cetuximab-IRDye800 for Surgical Navigation in Head and Neck Cancer. Clin Cancer Res 21:3658-66
de Boer, Esther; Warram, Jason M; Tucker, Matthew D et al. (2015) In Vivo Fluorescence Immunohistochemistry: Localization of Fluorescently Labeled Cetuximab in Squamous Cell Carcinomas. Sci Rep 5:10169