Lung Neoplasms
Conditions
Brief summary
This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
Interventions
DEVICETransbronchial Microwave Ablation
Transbronchial microwave ablation will be performed using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone.
Sponsors
Ethicon, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent. * Subjects greater or equal to 22 years old. * Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG). * Willing to fulfill all follow-up visit requirements. * Subjects with at least one oligometastatic lung tumor where the primary tumor is controlled (in the opinion of the investigator or treating oncologist). * Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura.
Exclusion criteria
* Pregnant or breastfeeding. * Subjects with thoracic implantable devices, including pacemakers or other electronic implants. * Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions. (However, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted). * Prior pneumonectomy. * Severe bronchiectasis (with FEV1 \<30%) or disease deemed to be too severe in the opinion of the investigator. * Platelet count ≤ 50,000/mm3. * Subjects with uncorrectable coagulopathy at time of screening. * Subjects medically unable to stop anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days prior to the procedure through 48-72 hours after the procedure. * Subjects medically unable to stop warfarin at least 3-5 days prior to the ablation procedure, or until INR \< 1.5, through 48-72 hours after the procedure. On the day of the procedure, subjects with an INR \> 1.5 cannot have the procedure completed that day but may be rescheduled or postponed. * Subjects medically unable to stop anticoagulants (e.g., rivaroxaban, apixaban, dabigatran, endoxaban) at least 3 days prior to the ablation procedure through 48-72 hours after the procedure. * Expected survival less than 6 months in the opinion of the investigator and/or treating oncologist. * Subjects with known or suspected brain metastases. * Subject has had any radiation (i.e., SBRT or EBRT) to the intended ablation zone. * Endobronchial tumors proximal to and including the segmental airways. * Lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned study ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation). * Systemic therapy (e.g., chemotherapy, targeted drug therapy, or immunotherapy) within 14 days prior to the planned study ablation procedure or those who plan to receive systemic therapy before completing the primary endpoint assessment (30 days post-ablation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Whose Ablation Resulted in Technique Efficacy | 30 days post-ablation | Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Whose Ablation Resulted in Technical Success | Immediately post-ablation (Day 0) | Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by the performing physician using CBCT imaging, immediately following the procedure. |
| Number of Patients Who Experienced Local Tumor Progression | Assessed at 3 months, 6 months and 1 year post-ablation | Local Tumor Progression, or recurrence of the originally ablated tumor(s) within or abutting the ablation zone, using the 30 day post-ablation imaging as baseline, was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging |
| Number of Patients Who Experienced Disease Progression | Assessed at 3 months, 6 months and 1 year post-ablation | Disease Progression includes local tumor progression (that is, recurrence of the target ablated tumor within or abutting the ablation zone) and regional tumor progression (that is, new or progression of non-ablated pre-existing tumors within the lung but outside the ablation zone) and distant tumor progression. Results for each category (local, regional, and distant tumor progression) are specified, as well as Overall Disease Progression. Disease Progression was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging as per treating physician assessment |
| Number of Patients Who Required Repeat Ablation of Target Lesion | Assessed at 3 months, 6 months and 1 year post-ablation | Number of patients that experienced a recurrence of the successfully ablated target lesion, as assessed at Day 30 post-ablation, and underwent a repeat ablation of the target Lesion |
Countries
Canada, Hong Kong, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transbronchial Microwave Ablation Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Transbronchial Microwave Ablation |
|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 10.73 |
| Primary Cancer Diagnosis Colorectal | 8 Participants |
| Primary Cancer Diagnosis Renal | 2 Participants |
| Primary Cancer Diagnosis Sarcoma | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
| Smoking Status Current Smoker | 2 Participants |
| Smoking Status Former Smoker | 7 Participants |
| Smoking Status Non-Smoker | 3 Participants |
| Stage at Time of Primary Cancer Diagnosis Stage I | 3 Participants |
| Stage at Time of Primary Cancer Diagnosis Stage II | 2 Participants |
| Stage at Time of Primary Cancer Diagnosis Stage III | 6 Participants |
| Stage at Time of Primary Cancer Diagnosis Stage IV | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 9 / 12 |
| serious Total, serious adverse events | 4 / 12 |
Outcome results
Primary
Number of Patients Whose Ablation Resulted in Technique Efficacy
Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure.
Time frame: 30 days post-ablation
Population: Patients analyzed at 30 days post-ablation. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transbronchial Microwave Ablation | Number of Patients Whose Ablation Resulted in Technique Efficacy | 11 Participants |
Secondary
Number of Patients Who Experienced Disease Progression
Disease Progression includes local tumor progression (that is, recurrence of the target ablated tumor within or abutting the ablation zone) and regional tumor progression (that is, new or progression of non-ablated pre-existing tumors within the lung but outside the ablation zone) and distant tumor progression. Results for each category (local, regional, and distant tumor progression) are specified, as well as Overall Disease Progression. Disease Progression was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging as per treating physician assessment
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Population: Patients analyzed 30 days post-ablation through the 1 year follow up period. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transbronchial Microwave Ablation | Number of Patients Who Experienced Disease Progression | Overall Disease Progression | 3 Participants |
| Transbronchial Microwave Ablation | Number of Patients Who Experienced Disease Progression | Local Tumor Progression | 0 Participants |
| Transbronchial Microwave Ablation | Number of Patients Who Experienced Disease Progression | Regional Tumor Progression | 3 Participants |
| Transbronchial Microwave Ablation | Number of Patients Who Experienced Disease Progression | Distant Tumor Progression | 2 Participants |
Secondary
Number of Patients Who Experienced Local Tumor Progression
Local Tumor Progression, or recurrence of the originally ablated tumor(s) within or abutting the ablation zone, using the 30 day post-ablation imaging as baseline, was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Population: Patients analyzed 30 days post-ablation through the 1 year follow up period. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transbronchial Microwave Ablation | Number of Patients Who Experienced Local Tumor Progression | 11 Participants |
Secondary
Number of Patients Who Required Repeat Ablation of Target Lesion
Number of patients that experienced a recurrence of the successfully ablated target lesion, as assessed at Day 30 post-ablation, and underwent a repeat ablation of the target Lesion
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Population: Patients analyzed 30 days post-ablation through the 1 year follow up period. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transbronchial Microwave Ablation | Number of Patients Who Required Repeat Ablation of Target Lesion | 0 Participants |
Secondary
Number of Patients Whose Ablation Resulted in Technical Success
Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by the performing physician using CBCT imaging, immediately following the procedure.
Time frame: Immediately post-ablation (Day 0)
Population: All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transbronchial Microwave Ablation | Number of Patients Whose Ablation Resulted in Technical Success | 12 Participants |