Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/2/2018
Start Date:April 23, 2018
End Date:July 30, 2021
Contact:Ohio State Comprehensive Cancer Center
Email:OSUCCCClinicaltrials@osumc.edu
Phone:800-293-5066

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

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.

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.

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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: John Phay
Phone: 614-293-7171
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mi
from
Columbus, OH
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