Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

The Ohio State University

Status: Completed

Conditions: Radical Lymph Node Dissection; Neck Dissection

Treatments: Procedure: Lymphangiography; Other: Indocyanine Green Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03532581

OSU-17368

NCI-2018-00390 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Treatment (ICG lymphangiography)

Experimental group

Description:

Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.

Treatment:

Procedure: Lymphangiography

Other: Indocyanine Green Solution