NRI-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01808417
First received: March 6, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Procedure: Near Infrared Imaging (NIR) for lymphatic mapping
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intraoperative NIR-Guided Sentinel Lymph Node Mapping in Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Feasibility of real-time intraoperative NIR lymphatic mapping [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Number of participants with adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identification of sentinel lymph nodes [ Time Frame: 2 years ]

Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NIR Lymphatic Mapping
NIR Lymphatic Mapping with indocyanine green
Procedure: Near Infrared Imaging (NIR) for lymphatic mapping

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808417

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Yolonda Colson, MD, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Yolonda L. Colson, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01808417     History of Changes
Other Study ID Numbers: 12-179
Study First Received: March 6, 2013
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014