Trial record 6 of 1493 for:    "Mayo Clinic" [Exact]

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by Mayo Clinic
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Shanda Blackmon, M.D., M.P.H., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02673021
First received: January 29, 2016
Last updated: NA
Last verified: January 2016
History: No changes posted
  Purpose
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Efficacy of microwave ablation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Pathological response in patients receiving microwave ablation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinical samples and imaging will be examined to determine pathological response.


Estimated Enrollment: 10
Study Start Date: February 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02673021

Contacts
Contact: Karlyn Pierson, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg 507-266-4819 lechtenberg.bettie@mayo.edu

Locations
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
Principal Investigator: Shanda Blackmon, MD, MPH Mayo Clinic
  More Information

No publications provided

Responsible Party: Shanda Blackmon, M.D., M.P.H., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02673021     History of Changes
Other Study ID Numbers: 15-001758 
Study First Received: January 29, 2016
Last Updated: January 29, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Lung Diseases
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 11, 2016