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
teaspoon.

- 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.

Inclusion Criteria:

- Suspected or histologically documented new non-small cell carcinoma that have agreed
to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as
recommended by their thoracic surgeon for treatment

- Surgically resectable lung cancer

- N2 lymph nodes negative on PET scan or mediastinoscopy

- Age > or equal to 18 years of age

- Men, women of non-child bearing age or women with a negative pregnancy test

Exclusion Criteria:

- Patient does not want to undergo subsequent surgical resection

- Medical condition such as uncontrolled infection or cardiac disease that, i the
opinion of the treating surgeon, makes resection unreasonably hazardous for the
patient.

- T4 or N2 disease

- Pre-operative spirometry that suggests they cannot undergo resection of their primary
tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy

- Iodide or seafood allergy

- Pregnant or lactating women