This early phase I trial studies how well ABY-029 works for the imaging head and neck cancer prior to surgery. ABY-029 is an experimental drug that may light up portions of many tumors. This trial aims to measure the amount of ABY-029 that reaches the head and neck cancer with the help of imaging devices. This information may help to guide future head and neck surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03282461.
PRIMARY OBJECTIVE:
I. To determine if microdoses of anti-EGFR fluorescence imaging agent ABY-029 (ABY-029) (up to 6X) lead to detectable signals (defined as signal-to-noise ratio, signal to noise ratio [SNR] >= 10, with wide-field intraoperative fluorescence imaging [iFI]) in sampled tissues with an EGFR pathology score >= 1 based on histological staining.
SECONDARY OBJECTIVE:
I. To assess ex vivo the specificity of tumor binding in resected specimens by measuring the corresponding molecular uptake and concentrations using histopathology.
OUTLINE:
Within 1-3 hours prior to standard of care surgery, patients receive ABY-029 intravenously (IV).
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorJoseph A. Paydarfar
