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

Not Applicable

Recruiting

• Conditions: Esophageal Cancer
• Interventions: Other: Injection of indocyanine green (ICG)dye; Device: Near-Infrared Image-Guided; Procedure: Sentinel Lymph Node (SLN) mapping

• Registration Number: NCT04400292
• Lead 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SLN mapping by NIR with ICG	Injection of indocyanine green (ICG)dye	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.
SLN mapping by NIR with ICG	Near-Infrared Image-Guided	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.
SLN mapping by NIR with ICG	Sentinel Lymph Node (SLN) mapping	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States