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

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

Study Overview

• Status: Terminated
• Conditions: Lung Neoplasms; Lung Cancer; Neoplasms, Lung; Pulmonary Neoplasms; Neoplasms, Pulmonary; Pulmonary Cancer; Cancer of Lung; Cancer of the Lung; Metastatic Cancer to the Lung
• Intervention / Treatment: Procedure: Microwave ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Microwave Ablation

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of microwave ablation.	Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment.	3 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response in patients receiving microwave ablation.	Clinical samples and imaging will be examined to determine pathological response.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Shanda Blackmon, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimated): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 15-001758; NCI-2022-10762 (Other Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO