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

N/AActive Not RecruitingNCT04400292

Memorial Sloan Kettering Cancer Center90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

Injection of indocyanine green (ICG)dyeOTHER

Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.

Near-Infrared Image-GuidedDEVICE

Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.

Sentinel Lymph Node (SLN) mappingPROCEDURE

Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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