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NIR-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer

NCT ID: NCT01808417

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-21

Study Completion Date

2015-04-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

There is no masking in this study as all study subjects receive the same intervention.

Study Groups

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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.

Group Type EXPERIMENTAL

Near Infrared Imaging

Intervention Type DRUG

The intervention to be administered is the drug indocyanine green.

Interventions

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Near Infrared Imaging

The intervention to be administered is the drug indocyanine green.

Intervention Type DRUG

Other Intervention Names

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NIR Lymphatic Mapping Indocyanine Green

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Yolonda L. Colson, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yolonda Colson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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12-179

Identifier Type: -

Identifier Source: org_study_id