Study of Cryoablation for Metastatic Lung Tumors

Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation
therapy, or a combination of treatments. However, several variables may exclude patients from
these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction,
or co-morbid medical conditions. For these patients, percutaneous cryoablation may be a
suitable option.

Ablation of metastatic lung tumors is a rapidly expanding area within interventional
oncology. Cryotherapy, radiofrequency, laser and microwave have all been shown to be
effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of
the ability to visualize the ice under imaging guidance and the preservation of collagenous
tissue structure. Cryoablation has been extensively performed in the prostate and kidney with
favorable outcomes reported in the literature. More recently, cryoablation has been shown to
be safe in the treatment of lung tumors with CT guidance.

Inclusion Criteria:

- Patient must be at least 18 years old.

- Patient has signed a written informed consent.

- Patient presents with Stage 4 pulmonary metastatic disease with metastatic disease
previously confirmed by prior biopsy; or Patient presents with Stage 4 pulmonary
metastatic disease previously confirmed on imaging (e.g. computerized tomography or
CT) with histology proven primary cancer.

- Patient has up to 6 local pulmonary metastases targetable by cryoablation.

- Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of
3.5 cm, measured in the longest cross sectional dimension.

- The target index tumor(s) is determined (by CT images) to be in a location where
cryoablation is technically achievable based on the proximity of adjacent organs/
structures and is greater than 0.5 cm from any critical organ/structure (possibly
achieved with additional maneuvers such as iatrogenic pneumothorax or
hydrodissection).

- Karnofsky Performance Scale (KPS) score greater than or equal to 60.

- Platelet count greater than 50,000/mm3 within 8 weeks prior to initial cryoablation
procedure.

- International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial
cryoablation procedure.

- Patient has a life expectancy of greater than 3 months.

Exclusion Criteria:

- Patient's index tumor(s) is primary lung cancer.

- Patient has uncontrollable primary or metastatic disease outside of the lung.

- Patient is unable to lie flat or has respiratory distress at rest.

- Patient has a coagulopathy or bleeding disorder which is uncontrolled.

- Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation
procedure.

- Patient has evidence of active systemic, pulmonary, or pericardial infection.

- Patient has a debilitating medical or psychiatric illness that would preclude giving
informed consent or receiving optimal treatment or follow up.

- Patient is currently participating in other experimental studies that could affect the
primary endpoint (e.g. experimental chemotherapy regimen).