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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Esophageal Cancer

Treatments: Other: Injection of indocyanine green (ICG)dye; Procedure: Sentinel Lymph Node (SLN) mapping; Device: Near-Infrared Image-Guided

Study type: Interventional

Funder types: Other

Identifiers

NCT04400292

20-201

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

90 participants in 1 patient group

SLN mapping by NIR with ICG

Experimental group

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.

Treatment:

Device: Near-Infrared Image-Guided

Procedure: Sentinel Lymph Node (SLN) mapping

Other: Injection of indocyanine green (ICG)dye