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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04400292

Enrollment

Registered

2020-05-22

Start date

2020-05-20

Completion date

2027-05-01

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Sentinel Lymph Node Mapping, lymphadenectomy, esophagectomy, ICG Injection, Intraoperative NIR Imaging, 20-201

Brief summary

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.

Interventions

OTHERInjection of indocyanine green (ICG)dye

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

DEVICENear-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.

PROCEDURESentinel Lymph Node (SLN) mapping

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

This will be a prospective single-arm study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniela Molena, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026