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OpenTrials
Active, Not Recruiting

NCT Number: NCT04400292

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of indocyanine green (ICG)dye

Other

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

Near-Infrared Image-Guided

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

Procedure

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

Primary outcomes

  1. The number of lymph nodes visualized to be fluorescent and nonfluorescent.

    Time frame: 1 year

    Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 22, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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