search
Back to results

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

Primary Purpose

Lung Neoplasms, Cancer of Lung, Cancer of the Lung

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave Ablation

Arm Description

Microwave Ablation

Outcomes

Primary Outcome Measures

Efficacy of microwave ablation.
Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment.
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.

Secondary Outcome Measures

Pathological response in patients receiving microwave ablation.
Clinical samples and imaging will be examined to determine pathological response.

Full Information

First Posted
January 29, 2016
Last Updated
October 2, 2023
Sponsor
Mayo Clinic
Collaborators
Medtronic - MITG
search

1. Study Identification

Unique Protocol Identification Number
NCT02673021
Brief Title
MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Acronym
MARK 1A
Official Title
MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding suspended prior to completing enrollment of all participants.
Study Start Date
June 8, 2016 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Medtronic - MITG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Metastatic Cancer to the Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microwave Ablation
Arm Type
Experimental
Arm Description
Microwave Ablation
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of microwave ablation.
Description
Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment.
Time Frame
3 months
Title
Assessment of patient adverse events as defined by CTCAE.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pathological response in patients receiving microwave ablation.
Description
Clinical samples and imaging will be examined to determine pathological response.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanda Blackmon, MD, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs