NCT01957787

Study of Cryoablation for Metastatic Lung Tumors

Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude participants from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these participants, 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.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
DEVICE	Cryoablation	Application of extremely cold temperatures to the identified tumor(s).

Timeline

• Start date: 2014-04-10
• Primary completion: 2017-03-09
• Completion: 2018-08-20
• First posted: 2013-10-08
• Last updated: 2021-07-19
• Results posted: 2019-08-28

Locations

10 sites across 2 countries: United States, France