Lung Cancer
Conditions
Keywords
primary, recurrent, metastatic lung tumor, ablation
Brief summary
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.
Detailed description
Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter and volume. Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure.
Interventions
DEVICEAblation
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
PROCEDURESurgical Resection
The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or authorized representative has provided informed consent. * Subject is ≥18 years of age. * At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter. * Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation. * Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. * ≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.
Exclusion criteria
* Pre-procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Response | 1 Day | Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection. |
| Ablation Zone Shape | Same day | Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete or Incomplete Tumor Ablation | Same Day | The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ablation and Surgical Resection All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Ablation and Surgical Resection |
|---|---|
| Age, Customized Age | 58.9 Years STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment Germany | 3 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 11 / 15 |
| serious Total, serious adverse events | 3 / 15 |
Outcome results
Primary
Ablation Zone Shape
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
Time frame: Same day
Population: Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablation and Surgical Resection | Ablation Zone Shape | 0.6 Ratio | Standard Deviation 0.2 |
Primary
Dose Response
Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.
Time frame: 1 Day
Population: Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation and Surgical Resection | Dose Response | % Change Ablation Zone Width (X) | -43.6 percent difference | Standard Deviation 18.8 |
| Ablation and Surgical Resection | Dose Response | % Change Ablation Zone Height (Y) | -15.1 percent difference | Standard Deviation 31.7 |
| Ablation and Surgical Resection | Dose Response | % Change Ablation Zone Depth (Z) | -32.8 percent difference | Standard Deviation 26 |
| Ablation and Surgical Resection | Dose Response | % Change (Actual Volume vs Predicted Volume) | -63.5 percent difference | Standard Deviation 26.3 |
| Ablation and Surgical Resection | Dose Response | % Change (Actual Calculated Vol. vs Predicted) | -57.7 percent difference | Standard Deviation 31.8 |
Secondary
Number of Participants With Complete or Incomplete Tumor Ablation
The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells.
Time frame: Same Day
Population: Secondary endpoint results were available for 11 subjects. For the secondary results, there were no tumors in four out of 15 samples (26.6%). Therefore, assessment of tumor cannot be made.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ablation and Surgical Resection | Number of Participants With Complete or Incomplete Tumor Ablation | Complete Ablation | 6 Participants |
| Ablation and Surgical Resection | Number of Participants With Complete or Incomplete Tumor Ablation | Incomplete Ablation | 4 Participants |
| Ablation and Surgical Resection | Number of Participants With Complete or Incomplete Tumor Ablation | Delayed Necrosis | 1 Participants |