MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Tab Title Description
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.
- 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.
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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
- 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.
- If subject has acute or chronic severe renal (kidney) insufficiency (glomerular filtration rate <30 mL/min/1.73m2 they will not receive contrast with imaging.
- Subject has renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.
- > 40 BMI
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Shanda Blackmon, M.D., M.P.H.
Closed for enrollment
Thoracic Surgery Research Unit
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available