MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Study Details
Study Description
Brief Summary
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
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
- Efficacy of microwave ablation. [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. [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
- Pathological response in patients receiving microwave ablation. [1 year]
Clinical samples and imaging will be examined to determine pathological response.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must be at least 18 years old.
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Subject is able to understand the study procedures and provide informed consent.
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Subject is willing and able to complete the entire study as specified in the protocol, including the follow-up visits.
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Subject has lung lesion that is biopsy-proven cancer (of any type) or suspicious, with confirmation at the time of the procedure.
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Lung lesion(s) are reachable/treatable per clinician opinion.
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Subject can have other location of disease if it is controlled, or there are plans for control.
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Subject has 1 or more lung nodules (not more than 10), that have a mean diameter <3 cm on axial CT scan.
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Life expectancy ≥6 months
Exclusion Criteria:
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Subject is pregnant or breast feeding.
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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.
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Subject has another location of disease that is not controlled, and there are no plans for control.
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Subject has more than 10 lung nodules.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55901 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 15-001758