Clinical Trials

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).