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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

Interventions

  • Other: Injection of indocyanine green (ICG)dye
    • Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.
  • Device: 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.
  • Procedure: Sentinel Lymph Node (SNL) mapping
    • Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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 I-III 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniela Molena, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Daniela Molena, MD, 212-639-3870, molenad@mskcc.org

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