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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04400292
• Other study ID #: 20-201
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Daniela Molena, MD
• Phone: 212-639-3870
• Email: molenad[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center