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MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s) (MARK 1A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Shanda Blackmon, M.D., M.P.H., Mayo Clinic

Brief Summary:
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?

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

Detailed Description:
Surgical resection is the gold standard treatment for localized non-small cell lung cancer (NSCLC). However, surgery is invasive and not all patients are surgical candidates, thus providing an opportunity for percutaneous microwave ablation, for both primary and metastatic disease. Patients that are deemed inoperable are typically treated with other targeted therapies such as radiofrequency ablation (RFA), cryoablation and stereotactic body radiation therapy (SBRT), or systemic therapies. Percutaneous microwave ablation (MWA) is an alternative option for targeted treatment of cancer. 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. Patients will be followed for 1 year by contrast enhanced chest CT, chest PET/CT and chest PET/MRI to evaluate lesion outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Microwave Ablation
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Pathological response in patients receiving microwave ablation. [ Time Frame: 1 year ]
    Clinical samples and imaging will be examined to determine pathological response.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years old.
  • Subject is able to understand the study procedures and provide informed consent.
  • Subject is willing and able to complete the entire study as specified in the protocol, including the follow-up visits.
  • Subject has lung lesion that is biopsy-proven cancer (of any type) or suspicious, with confirmation at the time of the procedure.
  • Lung lesion(s) are reachable/treatable per clinician opinion.
  • Subject can have other location of disease if it is controlled, or there are plans for control.
  • Subject has 1 or more lung nodules (not more than 10), that have a mean diameter <3 cm on axial CT scan.
  • Life expectancy ≥6 months

Exclusion Criteria:

  • Subject is pregnant or breast feeding.
  • Subject has a significant clinical disease or condition, e.g. cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematological, psychiatric or neurologic that would preclude enrollment, as determined by the primary investigator.
  • Subject has another location of disease that is not controlled, and there are no plans for control.
  • Subject has more than 10 lung nodules.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Medtronic - MITG
Investigators
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Principal Investigator: Shanda Blackmon, MD, MPH Mayo Clinic
Additional Information:
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Responsible Party: Shanda Blackmon, M.D., M.P.H., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02673021    
Other Study ID Numbers: 15-001758
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases