Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2023-03-07

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neck Dissection Radical Lymph Node Dissection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Indocyanine Green Solution

Intervention Type OTHER

Given Subcutaneous injection

Lymphangiography

Intervention Type PROCEDURE

Undergo lymphangiography

Interventions

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Indocyanine Green Solution

Given Subcutaneous injection

Intervention Type OTHER

Lymphangiography

Undergo lymphangiography

Intervention Type PROCEDURE

Other Intervention Names

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IC-GREEN ICG Solution Lymphography

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No