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 |
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.
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.
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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