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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-001758
    NCT ID: NCT02673021
    Sponsor Protocol Number: 15-001758

About this study

The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shanda Blackmon, M.D., M.P.H.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

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CLS-20187338

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