NCT02673021

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

January 29, 2016

Last Update Submit

October 2, 2023

Conditions

Lung NeoplasmsCancer of LungCancer of the LungLung CancerNeoplasms, LungNeoplasms, PulmonaryPulmonary CancerPulmonary NeoplasmsMetastatic Cancer to the Lung

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Pathological response in patients receiving microwave ablation.

    1 year

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

Microwave Ablation

Procedure: Microwave ablation

Interventions

Microwave ablationPROCEDURE

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.

Microwave Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shanda Blackmon, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 3, 2016

Study Start

June 8, 2016

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)