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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04400292

Collaborator

(none)

Enrollment

Location

Arm

35.4

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Esophageal Cancer	Other: Injection of indocyanine green (ICG)dye Device: Near-Infrared Image-Guided Procedure: Sentinel Lymph Node (SLN) mapping	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This will be a prospective single-arm study.This will be a prospective single-arm study.

Masking:

None (Open Label)

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 :

May 20, 2020

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	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 (SLN) mapping Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.

Arm

Intervention/Treatment

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.

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 (SLN) mapping

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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