Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging

Study Overview
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Brief Summary
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The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.

Official Title
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Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: Injection of indocyanine green (ICG)dye
* Device: Near-Infrared Image-Guided
* Procedure: Sentinel Lymph Node (SLN) mapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy. All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be eligible ≥18 years of age. Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection. Exclusion Criteria: No plan to undergo surgical resection. Severe iodide or seafood allergy. Women of childbearing potential without a negative pregnancy test; or women who are lactating. Prior diagnosis of severe hepatic or renal dysfunction. Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition) Patients with local recurrence and planning to undergo salvage esophagectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This will be a prospective single-arm study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLN mapping by NIR with ICG<br>Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer. | Other: Injection of indocyanine green (ICG)dye<br>* Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.<br>Device: Near-Infrared Image-Guided<br>* Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.<br>Procedure: Sentinel Lymph Node (SLN) mapping<br>* Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of lymph nodes visualized to be fluorescent and nonfluorescent. | Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Mapping, lymphadenectomy, esophagectomy, ICG Injection, Intraoperative NIR Imaging, 20-201