Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy

ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.

ECLIPSE is a treatment, Phase 1 multicenter, prospective, single-arm study with participants serving as their own control. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Participants will be followed for 5 years post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).

Inclusion Criteria:

• Participant must be at least 18 years old.
• Participant has signed a written informed consent.
• Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease.
• Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally.
• Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.
• The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.
• Eastern Cooperative Oncology Group (ECOG) score of 0-2.
• Karnofsky Performance Scale (KPS) score ≥60.
• Platelet count >50,000/cubed millimeters (mm^3) within 60 days prior to study treatment.
• International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.
• Participant has a life expectancy of >3 months.
• Participant is clinically suitable for cryoablation procedure.

Exclusion Criteria:

• Participant's primary cancer is lung cancer.
• Participant is unable to lie flat or has respiratory distress at rest.
• Participant has uncontrolled coagulopathy or bleeding disorders.
• Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure.
• Participant has a history of an allergic reaction to iodine injections or to shellfish.
• Participant has evidence of active systemic, pulmonary, or pericardial infection.
• Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
• Participant is currently participating in other experimental studies that could affect the primary endpoint.