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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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
Yolonda Colson, MD, PhD
Brigham and Women's Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|