Minimally Invasive Imagery With Indocyanine Green

According to the World Health Organization, lung cancer is the most common cause of
cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide
annually as of 2004.

Surgery remains the best option for patients presenting with operable Stage I or II cancers,
however the five year survival rate for these candidates remains at a dismal 53% for Stage I
and 32% for Stage II (1). The high rates of recurrence suggest that surgeons are unable to
completely detect and remove primary tumor nodules in a satisfactory manner as well as
lingering metastases in sentinel lymph nodes. By ensuring a negative margin through
near-infrared imagery it would be possible for us to improve the rates of recurrence free
patients and thus overall survival.

The use of an ICG probe will allow for the operating field and lung tissue to be observed in
real-time.

ICG has been used in the clinical settings since 1957. There is a wealth of data available
attesting to the safety of this drug injected at its current clinically indicated dosing
level. ICG has been shown to preferentially uptake in esophageal tumors as opposed to
surrounding epithelial lumen after one minute of IV exposure (2). Additionally, the same
group reported being able to better characterize the vascularization of the tumor to further
clarify the invasiveness of the cancer. ICG usage has been shown to be safe in a similar
clinical setting by the Gotoh group, who used ICG to detect and characterize bullous and
emphysematous lesion of the lung in video assisted thoracoscopic surgeries (VATS) with
Infrared Thoracoscopy that were not previously detectable by white light (3).

The currently proposed trial is a single center, open-label pilot/observational cohort study.
Patients with a diagnosis of resectable thoracic nodule/mass who are presumed to be
resectable via minimally invasive surgery as determined by pre-operative assessment at the
Hospital of the University of Pennsylvania will be included.

Inclusion Criteria:

1. Adult patients over 18 years of age

2. Patients presenting with a thoracic nodule presumed to be resectable cancer on
pre-operative assessment

3. Good minimally invasive operative candidates as determined by a thoracic oncology
multidisciplinary team

4. Subject capable of giving informed consent and participating in the process of
consent.

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin
(hCG) within 72 hours of surgery

2. Subjects with a history of iodide allergies

3. At-risk patient populations

1. Homeless patients

2. Patients with drug or alcohol dependence

3. Children and neonates

4. Patients unable to participate in the consent process