NIR-Guided Sentinel Lymph Node Mapping in Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/4/2017 |
| Start Date: | September 2010 |
| End Date: | April 2012 |
Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma
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 future studies.
ICG is a dye which has been in use since the 50s, and is approved for testing liver function
and measuring blood flow from the heart. It has been used in studies to map lymphatic
pathways in lung and breast cancer and information from those studies suggest it may help
identify lymph nodes associated with melanoma. ICG can be detected within the body using
near-infrared light cameras.
In this study the investigators are looking at how easily ICG can get to the first lymph
node (sentinel lymph node [SLN]) associated with melanoma, whether the investigators can see
the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the
best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it
does provide a small amount of radiation. This study will compare the investigators results
to the standard procedure.
green (ICG) in combination with near infrared (NIR) imaging to use for future studies.
ICG is a dye which has been in use since the 50s, and is approved for testing liver function
and measuring blood flow from the heart. It has been used in studies to map lymphatic
pathways in lung and breast cancer and information from those studies suggest it may help
identify lymph nodes associated with melanoma. ICG can be detected within the body using
near-infrared light cameras.
In this study the investigators are looking at how easily ICG can get to the first lymph
node (sentinel lymph node [SLN]) associated with melanoma, whether the investigators can see
the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the
best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it
does provide a small amount of radiation. This study will compare the investigators results
to the standard procedure.
At the time of surgery, you will undergo a lymphoscintigraphic procedure which is standard
of care for patients with melanoma. You will also receive a dose of ICG mixed with human
serum albumin. This will be administered in four small injections immediately around your
tumor or the tumor scar if it has already been removed. Pictures of the ICG solution will be
taken with the NIR camera and the progression of the dye along the lymphatic channel from
your tumor to the SLN will be monitored.
As each lymph node is removed, pictures will be taken to see if the ICG dye has entered and
colored that node. We will compare this technique with the results from the
lymphoscintigraphy to measure accuracy.
Patients will be followed for at least one hour post injection for adverse events. The
patient will then be taken off of the study. The results from each intervention will
subsequently analyzed.
of care for patients with melanoma. You will also receive a dose of ICG mixed with human
serum albumin. This will be administered in four small injections immediately around your
tumor or the tumor scar if it has already been removed. Pictures of the ICG solution will be
taken with the NIR camera and the progression of the dye along the lymphatic channel from
your tumor to the SLN will be monitored.
As each lymph node is removed, pictures will be taken to see if the ICG dye has entered and
colored that node. We will compare this technique with the results from the
lymphoscintigraphy to measure accuracy.
Patients will be followed for at least one hour post injection for adverse events. The
patient will then be taken off of the study. The results from each intervention will
subsequently analyzed.
Inclusion Criteria:
- Histologically confirmed melanoma and an appropriate surgical candidate for a
sentinel lymph node biopsy
- Stage of disease conducive to sentinel lymph node biopsy as determined by oncologic
surgeon
- Receiving a planned lymphoscintigraphy procedure
Exclusion Criteria:
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to indocyanine green, including those patients with a history of iodide
or seafood allergy
- Pregnant or breast-feeding
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
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials