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OpenTrials
Completed

NCT Number: NCT03532581

Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

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.

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Key information

Conditions

Neck Dissection Radical Lymph Node Dissection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine Green Solution

Other

Given Subcutaneous injection

Other names: IC-GREEN, ICG Solution

lymphangiography

Procedure

Undergo lymphangiography

Other names: Lymphography

Primary outcomes

  1. Identify thoracic duct (TD) using indocyanine green (ICG)

    Time frame: 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.

  2. Prevent injury to the TD

    Time frame: Up to 1 year

    Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.

  3. Recognize injury intra-operatively

    Time frame: Up to 1 year

    Will be mostly qualitative data collection on how the injury was identified and in what percent.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 22, 2018
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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