Lung Cancer Clinical Trial
— MARK 1AOfficial title:
MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Verified date | October 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?
Status | Terminated |
Enrollment | 9 |
Est. completion date | March 13, 2020 |
Est. primary completion date | March 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of microwave ablation. | Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment. | 3 months | |
Primary | Assessment of patient adverse events as defined by CTCAE. | 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. | 3 months | |
Secondary | Pathological response in patients receiving microwave ablation. | Clinical samples and imaging will be examined to determine pathological response. | 1 year |
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