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Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma

Phase 1
18 Years
Not Enrolling

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Trial Information

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
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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

We will analyze data immediately following each case, and analyze all collected data at 6 month intervals

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

April 2012

Related Keywords:

  • Melanoma
  • lymph node
  • Melanoma



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Brigham and Women's HospitalBoston, Massachusetts  02115