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

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injection of indocyanine green (ICG)dye
Near-Infrared Image-Guided
Sentinel Lymph Node (SLN) mapping
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring Sentinel Lymph Node Mapping, lymphadenectomy, esophagectomy, ICG Injection, Intraoperative NIR Imaging, 20-201

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SLN mapping by NIR with ICG

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2020
Last Updated
June 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04400292
Brief Title
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Sentinel Lymph Node Mapping, lymphadenectomy, esophagectomy, ICG Injection, Intraoperative NIR Imaging, 20-201

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a prospective single-arm study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SLN mapping by NIR with ICG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Injection of indocyanine green (ICG)dye
Intervention Description
Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.
Intervention Type
Device
Intervention Name(s)
Near-Infrared Image-Guided
Intervention Description
Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node (SLN) mapping
Intervention Description
Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.
Primary Outcome Measure Information:
Title
The number of lymph nodes visualized to be fluorescent and nonfluorescent.
Description
Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Molena, MD
Phone
212-639-3870
Email
molenad@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Smita Sihag, MD, MPH
Phone
212-639-3309
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Molena, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Molena, MD
Phone
212-639-3870

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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