NIR-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2017 |
| Start Date: | June 21, 2013 |
| End Date: | April 7, 2015 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials