Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2021

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

  • Other: Indocyanine Green Solution
    • Given Subcutaneous injection
  • Procedure: Lymphangiography
    • Undergo lymphangiography

Arms, Groups and Cohorts

  • Experimental: Treatment (ICG lymphangiography)
    • Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Phay, MD, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • John Phay, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center
  • Overall Contact(s)
    • Ohio State Comprehensive Cancer Center, 800-293-5066, OSUCCCClinicaltrials@osumc.edu

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