NIR-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer

Intraoperative NIR-Guided Sentinel Lymph Node Mapping in Esophageal Cancer

This research study is a Phase I clinical trial. Phase I clinical trials test the feasibility and safety of an investigational technique or drug. This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for further studies. "Investigational" means that this drug, ICG, is approved by the FDA for other imaging uses, but not for lymphatic mapping using NIR light. Its use for following lymphatic pathways from tumors in the human body is still being studied and research doctors are trying to find out more about it. It also means that the FDA has not approved ICG mapping for your type of cancer.

ICG is a dye and is approved for testing liver function and measuring blood flow from the heart. This drug has been used in studies to map lymphatic pathways in lung cancer and breast cancer and information from those other research studies suggests that this dye may help to identify lymph nodes associated with your esophageal tumor in this research study. ICG can be detected within the body using special near-infrared light cameras. In this research study, the investigators are looking at how easily ICG can get to the first lymph node (called the sentinel lymph node or SLN) associated with your esophageal tumor and whether the investigators can see the path of the ICG and the respective SLN using a near infrared camera.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Near Infrared Imaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Near Infrared Imaging; The intervention to be administered is the indocyanine green for NIR Lymphatic Mapping. All study subjects will receive this same intervention; there is only one arm.	Drug: Near Infrared Imaging; The intervention to be administered is the drug indocyanine green.; Other Names: Indocyanine Green; NIR Lymphatic Mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of real-time intraoperative NIR lymphatic mapping	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Safety data will be presented for all patients enrolled in the trial and will be presented according to dose level of indocyanine green. One summary will include a description of adverse events, by patient. Adverse event data will also be presented in frequency tables (overall and by intensity) by body system.	2 years
Identification of sentinel lymph nodes	To determine how easily ICG can get to the first lymph node (called the sentinel lymph node or SLN) associated with the esophageal tumor and whether the investigators can see the path of the ICG and the respective SLN using a near infrared camera.	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Yolonda Colson, MD, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2013
• Primary Completion (Actual): April 11, 2014
• Study Completion (Actual): April 7, 2015

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 12-179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: As of right now, there is no plan to make IPD available to other researchers.