Clinical trial NCT02673021: MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Official title: MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Neoplasms
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Metastatic Cancer to the Lung
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2016-02-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?

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 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.

Primary outcomes:
measure: Efficacy of microwave ablation.
timeFrame: 3 months
measure: Assessment of patient adverse events as defined by CTCAE.
timeFrame: 3 months
Secondary outcomes:
measure: Pathological response in patients receiving microwave ablation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shanda Blackmon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: