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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2020
CompletedStudy Start
First participant enrolled
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJuly 3, 2025
July 1, 2025
6 years
May 20, 2020
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of lymph nodes visualized to be fluorescent and nonfluorescent.
Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.
1 year
Study Arms (1)
SLN mapping by NIR with ICG
EXPERIMENTALPatients 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.
Interventions
Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.
Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.
Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Molena, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 22, 2020
Study Start
May 20, 2020
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.