Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

NCT03532581 | Completed DMC

• 2 other identifiers: OSU-17368NCI-2018-00390
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Dissection; Radical Lymph Node Dissection

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Treatment (ICG lymphangiography)

EXPERIMENTAL

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; Procedure: Lymphangiography

Interventions

Indocyanine Green Solution OTHER

Given Subcutaneous injection

Also known as: IC-GREEN, ICG Solution

Treatment (ICG lymphangiography)

Lymphangiography PROCEDURE

Undergo lymphangiography

Also known as: Lymphography

Treatment (ICG lymphangiography)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John Phay, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 22, 2018
• Study Start: April 23, 2018
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)