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NCT04400292 | RECRUITING | Esophageal Cancer

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

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Esophageal Cancer

Intervention/treatment

Injection of indocyanine green (ICG)dye

Near-Infrared Image-Guided

Sentinel Lymph Node (SLN) mapping

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official 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
Actual Study Start Date : 2020-05-20
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging

Location Details

NCT04400292

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065