This early phase I trial studies whether ABY-029, an anti-EGFR fluorescence imaging agent, can be seen in patients with sarcoma undergoing surgery. ABY-029 can light up portions of many tumors, making them glow a green color. This study is being done to see if ABY-029 can be detected in patients with sarcoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03154411.
PRIMARY OBJECTIVES:
I. To determine if microdoses of anti-EGFR fluorescence imaging agent ABY-029 (ABY-029) (up to 6X) lead to detectable signals, defined as having a signal-to-noise ratio (SNR) >= 10 with near-infrared (NIR) imaging, in sampled tissues with an EGFR pathology score >= 1 based on histological staining, and compare SNR to tissues with an EGFR pathology score < 1.
SECONDARY OBJECTIVES:
I. To assess if the spatial patterns of EGFR expression correlate with the tumor targeting of ABY-029 detection by NIR imaging relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.
OUTLINE:
Beginning 1-3 hours before surgery, patients receive anti-EGFR fluorescence imaging agent ABY-029 intravenously (IV). Patients then undergo surgery.
After completion of study, patients are followed up for 30 days after surgery.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorEric Henderson
