Completed

Intraoperative NIR-Guided Sentinel Lymph Node Mapping in Esophageal Cancer

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What is being tested

Near Infrared Imaging

Drug
Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Esophageal Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute
Last updated: December 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 21, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorDana-Farber Cancer Institute
Last updated: December 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteEsophageal Neoplasms

Criteria

2 inclusion criteria required to participate
Deemed an appropriate surgical candidate with consent for esophagectomy and lymphadenectomy or staging lymphadenectomy by their thoracic surgeon

Suspected or confirmed esophageal cancer

3 exclusion criteria prevent from participating
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

Patients who choose not to proceed with surgery

Women who are pregnant or breastfeeding

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps

Dana-Farber Cancer Institute

Boston, United States
Completed2 Study Centers