Neck Dissection, Radical Lymph Node Dissection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Given Subcutaneous injection
PROCEDURELymphangiography
Undergo lymphangiography
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery
Exclusion criteria
* Children, minors, pregnant women, women who are breast feeding, institutionalized patients * Known prior allergic reaction to ICG or allergy to iodine * Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify thoracic duct (TD) using indocyanine green (ICG) | Up to 1 year | 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. |
| Prevent injury to the TD | Up to 1 year | Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury. |
| Recognize injury intra-operatively | Up to 1 year | Will be mostly qualitative data collection on how the injury was identified and in what percent. |
Countries
United States
Outcome results
None listed