Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

Not Applicable

Completed

• Conditions: Neck Dissection; Radical Lymph Node Dissection
• Interventions: Other: Indocyanine Green Solution; Procedure: Lymphangiography

• Registration Number: NCT03532581
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-04-19
• Study Start: 2018-04-23
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (ICG lymphangiography)	Lymphangiography	Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.
Treatment (ICG lymphangiography)	Indocyanine Green Solution	Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.

Primary Outcome Measures

Name	Time	Method
Recognize injury intra-operatively	Up to 1 year	Will be mostly qualitative data collection on how the injury was identified and in what percent.
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.
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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States