Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
- This study is designed to determine the feasibility, safety amd dosing for indocyanine
green and near-infrared fluorescent light in order to maximize the near infrared-guided
detection of tumor-specific sentinel lymph nodes during the routine surgery for early
stage lung cancer when the tumor and nearby lymph nodes are removed.
- At the time of surgery, the indocyanine dye will be injected into or around the
patient's tumor. We are using a dose approximately 10,000 times lower than previously
approved for injection in the blood. After a few minutes, the surgeon will remove the
lymph nodes near the tumor, as is standard for lung surgery, and we will look at these
lymph nodes with near-infrared fluorescence.
- The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so
that the surgeon can identify the lymph nodes most likely to contain tumor cells. If
the lymph node is not found in the group of nodes usually removed, we will use the
near-infrared light to look near the tumor for the sentinel lymph nodes and guide the
surgeon so that the sentinel nodes can be removed and studied. The surgeon will then
continue with the operation and remove the tumor. The lymph nodes are processed for
special analysis tailored to finding metastasis in sentinel lymph nodes.
- Since the first question of this study is to determine the smallest dose of indocyanine
green that can be used safely for near-infrared detection of the lymph nodes, not all
subjects will receive the same dose. The most any person will receive is 1/3 of a
- A five year observation period begins following the operation during which surgeons and
physicians will examine the patient and order certain studies to look for evidence of
regrowth of the tumor.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To evaluate the safety and efficacy of near-infrared technology to guide therapeutic sentinel lymph node dissection in patients with lung cancer.
Yolonda L. Colson, MD, PhD
Brigham and Women's Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|