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

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.

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.