A Pilot Study of a Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer in Combination With Indo-Cyanine Green

This research study is a Pilot Study, which is the first time investigators are examining
this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved
Indocyanine Green for your specific disease, but it has been approved for other uses.

In this research study, the investigators are interested in learning how a new
investigational device, the FluoSCOPE, performs in the operating room. This study will also
allow the investigators to optimize the settings of the imaging system. The investigators
hope that this device, along with the local injection of Indocyanine Green around the tumor,
will help find the sentinel lymph nodes in real-time during the surgery to remove lung
cancer.

Although this is the first time the FluoSCOPE is being used in humans, the technology of
near-infrared fluorescence imaging has been used for the detection of sentinel lymph nodes
of patients with breast cancer, skin cancer and lung cancer.

Inclusion Criteria:

- Participants must meet the following criteria on screening examination to be eligible
to participate in the study:

- Participant must have histologically confirmed lung cancer and be deemed an
appropriate surgical candidate for thoracoscopic lung resection and will haveconsent
for a sentinel lymph node mapping by their oncologic surgeon. These patients will
have invasive non-small cell lung cancers for which thoracoscopic mediastinal lymph
node dissection at the time of thoracoscopic lung resection is standard of care. The
extent of lung resections in potential trial patients could span from sublobar
resection (i.e. wedge resection) to pnueumonectomy, though it is anticipated that
most patients will be undergoing the most common anatomic operation for lung cancer
which is lobectomy.

All stages of lung cancer that would otherwise be undergoing thoracoscopic lung resection
and mediastinal lymph node dissection would be eligible.

- Age minimum: 18 years.

- The minimum eligible subject age for this trial is 18 years. Individuals older than
age 18 are typically cared for in adult oncology clinics at our institutions.
Individuals under the age of 18 are excluded because safety studies including dosing
or adverse event data in this population are currently not available. Essentially
all of the patients operated upon for lung cancer at the BIDMC are adult men and
women. Because of the nature of this disease, we do not anticipate, and will not be,
enrolling any children into the study.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Participants who exhibit any of the following conditions at screening will not be
eligible for admission into the study.

- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.

- Participants who are receiving any other investigational agents.

- Participants with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse
events.

- 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.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Women who are pregnant or may become pregnant, as well as those women who are
breastfeeding, will be excluded from this study. Pregnant women are excluded from
this study because there is unknown risk associated with ICG (US FDA Risk Category C:
there are no controlled studies in women, or no studies are available in either
animals or women). Because there is an unknown, but potential, risk of adverse events
in nursing infants secondary to treatment of the mother, breastfeeding should be
discontinued if the mother is treated.

- Patients in whom the tumor might not be accessible for peritumoral injection of
indocyanine green, e.g. small, central tumors.

- No other appropriate agent-specific exclusion criteria.