Lung NeoplasmsMARK 1ANCT02673021
MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
A study testing Microwave ablation in people with Lung Neoplasms and Cancer of Lung, run by Mayo Clinic at 2 sites in United States.
Trial summary
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Cancer of Lung, Cancer of the Lung
- What is being tested?
- Microwave ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2016to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55901
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?
Read the 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.
- Conditions
- Lung Neoplasms, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary
- Being tested
- Microwave ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation | Experimental | Microwave Ablation Receives: Procedure: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of microwave ablation.
Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment.
Measured: 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.
Measured: 3 months
Secondary outcomes (1)
Pathological response in patients receiving microwave ablation.
Clinical samples and imaging will be examined to determine pathological response.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start8 Jun 2016
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: Funding suspended prior to completing enrollment of all participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Shanda Blackmon, M.D., M.P.H., Mayo Clinic
- Investigators
- Shanda Blackmon, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673021
- Sponsor's protocol ID
- 15-001758
- Other IDs
- NCI-2022-10762
- Acronym
- MARK 1A
- Status last verified
- Oct 2023
- First submitted
- 29 Jan 2016
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
- ClinicalTrials.gov ID
- NCT02673021
- Acronym / sponsor ID
- MARK 1A / 15-001758
- Conditions
- Lung Neoplasms, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding suspended prior to completing enrollment of all participants.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation | Experimental | Procedure: Microwave ablationMicrowave Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablationMicrowave 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. | Procedure or surgery | Microwave Ablation |
Primary outcome
Efficacy of microwave ablation.
Time frame: 3 months
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.
Time frame: 3 months
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.
1 secondary outcome
Pathological response in patients receiving microwave ablation.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Funding suspended prior to completing enrollment of all participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanda Blackmon, MD, MPH principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Lung Neoplasms and Cancer of Lung, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding suspended prior to completing enrollment of all participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of microwave ablation. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.