Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Completed · Not applicable

Conditions studied: Metastatic Lung Cancer

In brief

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.

Key facts

Study ID

NCT01307501

Run by

Boston Scientific Corporation

People needed

40

Starts

2012-01-04

Expected to finish

2018-08-30

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ronald Regan UCLA Medical Center — Los Angeles, California, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Institut Gustave Roussy — Villejuif, Cedex, France

Full record on ClinicalTrials.gov

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