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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2026-05-31

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.

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Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be a prospective single-arm study.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SLN mapping by NIR with ICG

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.

Group Type EXPERIMENTAL

Injection of indocyanine green (ICG)dye

Intervention Type OTHER

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

Near-Infrared Image-Guided

Intervention Type DEVICE

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) mapping

Intervention Type PROCEDURE

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

Interventions

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Injection of indocyanine green (ICG)dye

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

Intervention Type OTHER

Near-Infrared Image-Guided

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

Intervention Type DEVICE

Sentinel Lymph Node (SLN) mapping

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No