This trial is active, not recruiting.

Condition neoplasm metastasis
Treatment cryoablation
Sponsor Galil Medical
Start date March 2014
End date April 2017
Trial size 134 participants
Trial identifier NCT01957787, CUC13-LNG079


The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in patients with pulmonary metastatic disease. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation procedure.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Freezing of the tumor(s)
cryoablation Cryotherapy
All patients will receive cryoablation of up to 6 metastatic lung tumors.

Primary Outcomes

Local tumor control for each index tumor as measured by imaging
time frame: 12 months post-cryoablation

Secondary Outcomes

Safety assessment
time frame: 30 days post-cryoablation

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Multi-center Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Galil Medical.
Location data was received from the National Cancer Institute and was last updated in April 2016.