MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s) (MARK 1A)
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|ClinicalTrials.gov Identifier: NCT02673021|
Recruitment Status : Terminated (Funding suspended prior to completing enrollment of all participants.)
First Posted : February 3, 2016
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Metastatic Cancer to the Lung||Procedure: Microwave ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||March 13, 2020|
|Actual Study Completion Date :||March 13, 2020|
Experimental: Microwave Ablation
Procedure: Microwave ablation
Microwave tumor ablation is a procedure that uses heat made by an electric current to destroy a tumor (ablation). With imaging equipment, such as ultrasound or CT (computed tomography), and a small incision made in the skin, the tumor is located and treated with radiofrequency energy. The cells that are killed by the microwave ablation are typically not removed but are eventually replaced by fibrosis and scar tissue.
- Efficacy of microwave ablation. [ Time Frame: 3 months ]Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment.
- Assessment of patient adverse events as defined by CTCAE. [ Time Frame: 3 months ]The safety evaluation is based on the major complication rates of performing microwave ablation. The intent is to determine if the results are within acceptable range of what is reported for RFA, cryoablation and surgery. If the microwave ablation has a safety profile that is outside the "standard of care" range, then the procedure would be deemed unacceptable and no further studies of the current generation of microwave ablation would be recommended. The study team has deemed major complication rates of 50% or greater as outside of the "standard of care" range.
- Pathological response in patients receiving microwave ablation. [ Time Frame: 1 year ]Clinical samples and imaging will be examined to determine pathological response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673021
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Shanda Blackmon, MD, MPH||Mayo Clinic|