Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection

Conditions
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Neck Dissection, Radical Lymph Node Dissection

Intervention / Treatment
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* Other: Indocyanine Green Solution
* Procedure: Lymphangiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (ICG lymphangiography)<br>Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery. | Other: Indocyanine Green Solution<br>* Given Subcutaneous injection<br>* Other names: ICG Solution;Procedure: Lymphangiography<br>* Undergo lymphangiography<br>* Other names: Lymphography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 1 year | 
| Recognize injury intra-operatively | Will be mostly qualitative data collection on how the injury was identified and in what percent. | Up to 1 year |