This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.
PRIMARY OBJECTIVES: I. Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography. II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively. III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field. OUTLINE: Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery. After completion of study treatment, participants are followed up for up to 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
48
Given Subcutaneous injection
Undergo lymphangiography
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Identify thoracic duct (TD) using indocyanine green (ICG)
We will determine in how many patients the thoracic duct is identified by white light visualization and by ICG fluorescence. The collected data will be primarily qualitative as determined by the surgeon.
Time frame: Up to 1 year
Prevent injury to the TD
Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.
Time frame: Up to 1 year
Recognize injury intra-operatively
Will be mostly qualitative data collection on how the injury was identified and in what percent.
Time frame: Up to 1 year
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