POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)

• ClinicalTrials.gov Identifier: NCT05299606
• Recruitment Status: Recruiting
• First Posted: March 29, 2022
• Last Update Posted: April 24, 2024
• Sponsor: Ethicon, Inc.
• Information provided by (Responsible Party): Ethicon, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Neoplasms	Device: Transbronchial Microwave Ablation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 145 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
• Actual Study Start Date: October 24, 2022
• Estimated Primary Completion Date: January 31, 2025
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Transbronchial 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.	Device: Transbronchial 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.

Outcome Measures

Primary Outcome Measures :

1. Technique Efficacy [ Time Frame: 30 days (-7 to +14 days) post-ablation ]
   Ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) using CT imaging.

Secondary Outcome Measures :

1. Technical Success [ Time Frame: Immediately post-ablation (day 0) ]
   A complete tumor ablation with a surrounding minimal margin as assessed by cone beam CT imaging.
2. Navigational Success [ Time Frame: During navigation (day 0) ]
   Successful navigation to the targeted peripheral lung tumor(s) as confirmed using cone beam CT.
3. Local Tumor Progression [ Time Frame: 12-month visit ]
   Recurrence of the originally ablated target tumor(s) within or abutting the ablation zone using the 30-day post-ablation imaging as the baseline.
4. Local Tumor Progression Free Survival [ Time Frame: 12-month visit ]
   Time from the ablation until local tumor(s) progression or death, whichever occurs first.
5. Progression Free Survival [ Time Frame: 12-month visit ]
   Time from the original ablation until tumor(s) progression or death, whichever occurs first (includes local, regional, or distant progression).
6. Disease (cancer) Specific Survival [ Time Frame: 12-month visit ]
   Time from the original ablation until death from the treated primary malignancy.
7. Overall Survival [ Time Frame: 12-month visit ]
   Time from the original ablation until subject death (includes death from any cause).
8. Repeat Ablation Efficacy Rate [ Time Frame: 12-month visit ]
   Rate of original tumors that have been re-ablated successfully (i.e., Technical Success of tumors that have been re-ablated out of all original tumors that have been re-ablated).
9. Change in Pulmonary Function Tests (Spirometry I) [ Time Frame: 12-month visit ]

   Change in all available (i.e., what is site standard-of-care) spirometry tests from pre-ablation baseline values to values at 3-months, 6-months, and 12-months post-ablation.

   Spirometry tests are non-invasive and measure how much air one can breathe in and out of one's lungs, as well as how easily and fast one can the blow the air out of one's lungs. These tests include FVC (forced vital capacity, % of predicted), FEV1 (forced expiratory volume, % of predicted), FEV1/FVC (% ratio), and FEV 25-75 (average flow at which 25% has been exhaled through the point which 75% has been exhaled), all of which are expressed as a percentage.

10. Change in Pulmonary Function Tests (Spirometry II) [ Time Frame: 12-month visit ]

    Change in peak expiratory flow and maximum ventilation volume spirometry tests from pre-ablation baseline values to values at 3-months, 6-months, and 12-months post-ablation.

    Peak Expiratory Flow is the maximal rate that one can exhale during a short maximal expiratory effort after a full inspiration and Maximum Ventilation Volume is the maximum minute volume of ventilation that one can maintain for 12-15 seconds. Both tests are expressed as L/min.

11. Change in Pulmonary Function Tests (Diffusion Capacity) [ Time Frame: 12-month visit ]

    Change in diffusion capacity from the pre-ablation baseline value to values at 3-months, 6-months, and 12-months post-ablation.

    The diffusion capacity test measures the volume of carbon monoxide transferred from the lung to blood and is measured in ml/min/mmHg and put into a percentage (% of predicted).

12. Change in Pulmonary Function Tests (Lung Volume) [ Time Frame: 12-month visit ]

    Change in lung volume from the pre-ablation baseline values to values at 3-months, 6-months, and 12-months post-ablation.

    The lung volume tests include plethysmographic TLC (total lung capacity), plethysmographic FRC (functional residual capacity), plethysmographic RV (residual volume), gas dilution TLC, gas dilution FRC, and gas dilution RV. A plethysmograph measures changes in volume within an organ and a gas dilution test may determine lung volumes that cannot be determined from simple spirometry. All assessments are collected in liters (L) and put into a percentage (% of predicted).

13. Change in EORTC QLQ-C30 [ Time Frame: 12-month visit ]
    Change in quality of life scores per the validated EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 questionnaire from pre-ablation baseline scores to scores at 3-months, 6-months, and 12-months post-ablation. The questionnaire asks cancer patients to choose a response that most closely describes them for 30 questions on a scale from 1-4 (1 being 'not at all', 2 being 'a little', 3 being 'quite a bit' and 4 being 'very much). The 30 questions are separated into sections for 'general quality of life', 'during the past week', and 'overall health and quality of life'.
14. Change in EORTC QLQ-LC13 [ Time Frame: 12-month visit ]
    Change in quality of life scores per the validated EORTC (European Organization for Research and Treatment of Cancer) QLQ-LC13 questionnaire from pre-ablation baseline scores to scores at 3-months, 6-months, and 12-months post-ablation. The questionnaire asks lung-cancer patients to choose a response that most closely describes them for 13 questions on a scale from 1-4 (1 being 'not at all', 2 being 'a little', 3 being 'quite a bit' and 4 being 'very much). The 13 questions are all about symptoms and problems experienced during the past week.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Contacts

Contact: Erin Meyers, MBA; 937-681-0322; eprifog1@its.jnj.com

Locations

United States, California

Stanford University School of Medicine; Recruiting

Stanford, California, United States, 94305

United States, Connecticut

UCONN Health; Recruiting

Farmington, Connecticut, United States, 06030

United States, Minnesota

Minnesota Lung Center; Recruiting

Minneapolis, Minnesota, United States, 55407

United States, North Carolina

FirstHealth Moore Regional Hospital; Recruiting

Pinehurst, North Carolina, United States, 28374

United States, Ohio

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

MD Anderson; Recruiting

Houston, Texas, United States, 77030

Canada, Ontario

University of Toronto; Not yet recruiting

Toronto, Ontario, Canada

Canada, Quebec

Centre Hospitalier de l'Universite de Montreal; Recruiting

Montreal, Quebec, Canada

Hong Kong

Prince of Wales Hospital; Recruiting

Sha Tin, Hong Kong

Sponsors and Collaborators

Ethicon, Inc.

More Information

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT05299606
• Other Study ID Numbers: NEU_2020_03
• First Posted: March 29, 2022
• Last Update Posted: April 24, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
• URL: http://yoda.yale.edu

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases