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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-08

Study Completion Date

2020-03-13

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lung Neoplasms Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Metastatic Cancer to the Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microwave Ablation

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No