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出境医 / 临床实验 / MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s) (MARK 1A)

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE January 29, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date June 29, 2020
Study Start Date  ICMJE February 2016
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016) 		Pathological response in patients receiving microwave ablation. [ Time Frame: 1 year ]
Clinical samples and imaging will be examined to determine pathological response.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Official Title  ICMJE MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Brief Summary Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Neoplasms
  • Cancer of Lung
  • Cancer of the Lung
  • Lung Cancer
  • Neoplasms, Lung
  • Neoplasms, Pulmonary
  • Pulmonary Cancer
  • Pulmonary Neoplasms
  • Metastatic Cancer to the Lung
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Microwave Ablation
Microwave Ablation
Intervention: Procedure: Microwave ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 25, 2020) 		6
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016) 		10
Actual Study Completion Date  ICMJE March 13, 2020
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02673021
Other Study ID Numbers  ICMJE 15-001758
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanda Blackmon, M.D., M.P.H., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Medtronic - MITG
Investigators  ICMJE
Principal Investigator: Shanda Blackmon, MD, MPH Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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