Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine the feasibility of real-time intraoperative NIR lymphatic mapping with concurrent identification of the sentinel lymph node in human melanoma using indocyanine green.
We will analyze data immediately following each case, and analyze all collected data at 6 month intervals
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|