Study of Cryoablation for Metastatic Lung Tumors

Completed · Not applicable

Conditions studied: Neoplasm Metastasis

In brief

The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. 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 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.

Key facts

Study ID

NCT01957787

Run by

Boston Scientific Corporation

People needed

131

Starts

2014-04-10

Expected to finish

2018-08-20

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 Participant presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (for example, computerized tomography or CT) with histology proven primary cancer.
• Participant 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/millimeters (mm)\^3 within 8 weeks prior to initial cryoablation procedure.
• International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
• Participant has a life expectancy of greater than 3 months.

You may not qualify if…

• Participant's index tumor(s) is primary lung cancer.
• Participant has uncontrollable primary or metastatic disease outside of the lung.
• Participant is unable to lie flat or has respiratory distress at rest.
• Participant has a coagulopathy or bleeding disorder which is uncontrolled.
• Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation procedure.
• 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 (for example, experimental chemotherapy regimen).

Where it is running

• UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
• Cancer Treatment Centers of America at Southeastern Regional Medical Center — Newnan, Georgia, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• New York Presbyterian Hospital - Cornell Medical Center — New York, New York, United States
• State University of New York at Stony Brook — Stony Brook, New York, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Inova Alexandria Hospital CVIR — Alexandria, Virginia, United States
• Institut Bergonié — Bordeaux, Aquitaine, France
• Institut Gustave Roussy — Villejuif, Île-de-France Region, France

Full record on ClinicalTrials.gov

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