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Intraoperative NIR-Guided Sentinel Lymph Node Mapping in Esophageal Cancer

Phase 0
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Intraoperative NIR-Guided Sentinel Lymph Node Mapping in Esophageal Cancer

If you are willing to participate in this study you will be asked to undergo a review of
your medical history to confirm that you are eligible. If this review shows that you are
eligible you will begin the study treatment. If you do not meet the eligibility criteria,
you will not be able to participate in the research study.

Your primary surgeon will coordinate the date and time of surgery with you, and the hospital
will confirm this schedule.

At the time of surgery, a dose of ICG mixed with normal saline, a solution of salt and
water, will be administered in four small injections immediately around your tumor. You will
receive approximately half a teaspoon of the normal saline/ICG solution. You will be under
general anesthesia. Pictures of the ICG solution will be taken with the NIR camera and the
progression of the dye, as it makes its way along the lymphatic channel from the location of
your tumor to the SLN, will be monitored. After five to fifteen minutes, the surgeon will
continue with your procedure, removing the lymph nodes according to standard or care. The
surgeon will discuss this with you ahead of time.

As each lymph node is removed, we will take a picture of it to see if the ICG dye has
entered and colored that node.

Following the removal of your lymph nodes, your surgeon will complete the operation and you
will continue to be monitored for 30 minutes for any rare but possible side effects
(allergic reactions) to the ICG. You will then be removed from the study. With the exception
of the administration of the ICG and photography with the NIR camera, there will be no
changes from the standard of care.

Following your surgery, we will collect the final pathology results from your procedure.
Because we are only looking at determining the feasibility of this technique using NIR
imaging, we do not wish to follow you for any period of time following the procedure. If you
experience a rare but possible side effect from the ICG, normal saline, or NIR light, we
will continue to monitor you until the condition is resolved.

Inclusion Criteria:

- Suspected or confirmed esophageal cancer

- Deemed an appropriate surgical candidate with consent for esophagectomy and
lymphadenectomy or staging lymphadenectomy by their thoracic surgeon

Exclusion Criteria:

- Patients who choose not to proceed with surgery

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to indocyanine green, including thos patients with a history of iodide or
seafood allergy

- Women who are pregnant or breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of real-time intraoperative NIR lymphatic mapping

Outcome Description:

To determine the feasibility of real-time intraoperative NIR lymphatic mapping with concurrent identification of the sentinel lymph node in esophageal cancer using indocyanine green

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Yolonda Colson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115