Microwave Ablation for Lung Cancer
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Ethicon, Inc.
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial tests a new procedure that uses microwave energy to destroy lung tumors. It targets patients with a few metastatic lung tumors. The treatment involves a device that heats and kills cancer cells, guided by robotic and imaging technology for accuracy. This developing treatment option offers advantages such as larger treatment areas and shorter heating times compared to other methods.
Do I need to stop my current medications for the trial?
Yes, you may need to stop certain medications. Specifically, you must stop anti-platelet agents at least 5 days before the procedure and for 48-72 hours after. You must also stop warfarin 3-5 days before the procedure until your INR is less than 1.5, and for 48-72 hours after. Additionally, you must stop anticoagulants at least 3 days before the procedure and for 48-72 hours after. Other medications are not specified in the protocol.
What data supports the idea that Microwave Ablation for Lung Cancer is an effective treatment?
The available research shows that Microwave Ablation (MWA) for lung cancer can be effective, especially when combined with chemotherapy. One study found that patients with stage IV lung adenocarcinoma who received MWA along with chemotherapy had better outcomes compared to those who only received chemotherapy. This suggests that MWA can help improve the time patients live without the cancer getting worse. Additionally, MWA is being explored as a safe and feasible option for patients who cannot undergo surgery, offering a local treatment for inoperable lung cancer.12345
What safety data is available for microwave ablation in lung cancer treatment?
The safety data for microwave ablation in lung cancer treatment includes a study comparing targeted percutaneous microwave ablation combined with mediastinal radiotherapy to radiotherapy alone in patients with locally advanced non-small cell lung cancer (NSCLC). The study found a significantly lower incidence of radiation pneumonia in the ablation group (3.9%) compared to the radiotherapy group (31.9%). Additionally, there are reports of pneumothorax occurring in patients who were candidates for microwave ablation and treated with EGFR-tyrosine kinase inhibitors, suggesting a potential risk of pneumothorax or bronchopleural fistula in these patients. Overall, while microwave ablation appears to have a lower risk of certain adverse effects like radiation pneumonia, there are other risks such as pneumothorax that need to be considered.678910
Is Transbronchial Microwave Ablation a promising treatment for lung cancer?
Eligibility Criteria
Adults (22+ years) with a few lung cancer spots, good performance status (able to carry out daily activities), and tumors in specific lung areas can join. They must not need continuous ventilator support, have severe lung damage, brain metastases, recent other lung treatments or be on certain blood thinners.Inclusion Criteria
Willing to fulfill all follow-up visit requirements
My lung tumor is in the outer part of the lung and not near the lung surface.
I can take care of myself and am up and about more than 50% of my waking hours.
See 4 more
Exclusion Criteria
I haven't had any systemic therapy like chemotherapy in the last 14 days.
I cannot stop taking my blood thinning medication for 5 days before and up to 3 days after a procedure.
I haven't had lung surgery or treatment in the last 30 days and won't have any before a month after joining the study.
See 13 more
Treatment Details
Interventions
- Transbronchial Microwave Ablation (Microwave Ablation)
Trial OverviewThe study tests a new way to treat small areas of cancer in the lungs using microwave energy guided by advanced robotic technology and CT scans. The goal is to see how well it works one month after treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transbronchial Microwave AblationExperimental Treatment1 Intervention
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.
Transbronchial Microwave Ablation is already approved in United States for the following indications:
🇺🇸 Approved in United States as NEUWAVE FLEX Microwave Ablation System for:
- Ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Temple UniversityPhiladelphia, PA
UCONN HealthFarmington, CT
FirstHealth Moore Regional HospitalPinehurst, NC
Minnesota Lung CenterMinneapolis, MN
More Trial Locations
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Who Is Running the Clinical Trial?
Ethicon, Inc.Lead Sponsor
References
Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. [2022]Endobronchial microwave ablation via flexible catheter offers the potential for local therapy for inoperable peripheral lung cancer. The study aimed to evaluate the feasibility and safety of navigation bronchoscopy-guided water-cooled microwave ablation catheter for nonsurgical peripheral lung cancer.
Management of bronchopleural fistula with endobronchial valve in hybrid operating room following transbronchial microwave ablation. [2022]Transbronchial microwave ablation for the treatment of lung nodules is gaining popularity. In the present case, transbronchial microwave ablation to a right middle lobe lesion was performed under electromagnetic navigation bronchoscopy guidance. It was complicated with pneumothorax and persistent air leak despite chest drainage and chemical pleurodesis. A diagnosis of bronchopleural fistula was reached and an endobronchial valve was implanted to the middle lobe segmental bronchus with almost immediate cessation of air leak. Our case demonstrated that endobronchial valve is safe and effective in managing bronchopleural fistula after transbronchial microwave ablation.
Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy. [2023]The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model.
Flexible bronchoscopy-guided microwave ablation in peripheral porcine lung: a new minimally-invasive ablation. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Transbronchial lung biopsy is an important approach to diagnose peripheral lung cancer, but bronchoscopy based treatment options are limited and poorly studied. A flexible bronchoscopy-guided water-cooled microwave ablation (MWA) catheter was developed to evaluate the feasibility and safety both in ex vivo and in vivo porcine models.
Microwave ablation combined with chemotherapy improved progression free survival of IV stage lung adenocarcinoma patients compared with chemotherapy alone. [2020]Microwave ablation (MWA) has recently become an established treatment option for topical therapy of lung cancer patients. In this study, we evaluated whether MWA combined with chemotherapy could improve progression-free survival (PFS) of patients with stage IV lung adenocarcinoma compared with chemotherapy alone.
Targeted percutaneous microwave ablation at the pulmonary lesion combined with mediastinal radiotherapy with or without concurrent chemotherapy in locally advanced non-small cell lung cancer evaluation in a randomized comparison study. [2018]Concurrent chemoradiotherapy is the standard treatment for patients with locally advanced lung cancer. The most common dose-limiting adverse effect of thoracic radiotherapy (RT) is radiation pneumonia (RP). A randomized comparison study was designed to investigate targeted percutaneous microwave ablation at pulmonary lesion combined with mediastinal RT with or without chemotherapy (ablation group) in comparison with RT (target volume includes pulmonary tumor and mediastinal node) with or without chemotherapy (RT group) for the treatment of locally advanced non-small cell lung cancers (NSCLCs). From 2009 to 2012, patients with stage IIIA or IIIB NSCLCs who refused to undergo surgery or were not suitable for surgery were enrolled. Patients were randomly assigned to the RT group (n = 47) or ablation group (n = 51). Primary outcomes were the incidence of RP and curative effectiveness (complete response, partial response, and stable disease); secondary outcome was the 2-year overall survival (OS). Fifteen patients (31.9%) in the RT and two (3.9%) in the ablation group experienced RP (P
Multi-organs perioperative immune-related adverse events and postoperative bronchial anastomotic fistula in a patient receiving neoadjuvant immunotherapy with NSCLC. [2022]The safety of neoadjuvant chemoimmunotherapy before surgery in patients with non-small cell lung cancer (NSCLC) remains unclear in the perioperative stage. We describe a case of a 63-year-old man with IIIC stage NSCLC who received neoadjuvant chemoimmunotherapy and radical lobectomy. After the second cycle of pembrolizumab and chemotherapy (paclitaxel + carboplatin), the patient was diagnosed with immunologic enterocolitis and relieved by glucocorticoid therapy. Radical lobectomy of the right upper lobe was then performed. On postoperative day 4 (POD 4), the patient suddenly suffered suffocated wheezing during sleep. Interstitial lung disease was, therefore, identified by chest computed tomography scan. Glucocorticoids and mechanical ventilation were applied and the symptoms were relieved. On POD 10, the patient developed a bronchial fistula and underwent emergent repair surgery. This is the first case of multi-organs, multi-time point immune-related adverse events (irAE) in perioperative NSCLC patients who received neoadjuvant chemoimmunotherapy. Clinicians should be on high alert for signs of irAEs in neoadjuvant chemoimmunotherapy patients, promptly requiring multidisciplinary management.
Pneumothorax triggered by EGFR-tyrosine kinase inhibitors in three microwave ablation candidates: A review of the literature. [2021]Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are widely used in patients with EGFR-mutant lung cancer. Meanwhile, thermal ablation such as microwave ablation has been an option for selected patients. Herein, we describe three cases of pneumothorax that occurred in microwave ablation (MWA) candidates treated with EGFR-TKIs. The three patients developed pneumothorax in different periods: case 1 developed pneumothorax two months after MWA and subsequent gefitnib therapy; case 2 took osimertinib for two years and developed pneumothorax before MWA; case 3 took gefitinb for 13 months and experienced bronchopleural fistula after MWA. Although a causal relationship is uncertain, the risk of pneumothorax for these MWA candidates should be considered. KEY POINTS: Microwave ablation candidates treated with epidermal growth factor receptor tyrosine kinase inhibitors are more likely to suffer pneumothorax. The risk of delayed pneumothorax or even bronchopleural fistula in patients pretreated with tyrosine kinase inhibitors should be taken into consideration when selecting patients and performing microwave ablations.
Real-World Costs of Adverse Events in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer. [2023]Non-small cell lung cancer (NSCLC) is the most common form of lung cancer in the United States. Immunotherapies and cytotoxic chemotherapies used to treat advanced NSCLC carry a substantial risk of adverse events (AEs), but real-world data on the incidence and costs associated with the unique AE profiles of these treatments are sparse.
Clinical recommendations for perioperative immunotherapy-induced adverse events in patients with non-small cell lung cancer. [2022]Perioperative adjuvant treatment has become an increasingly important aspect of the management of patients with non-small cell lung cancer (NSCLC). In particular, the success of immune checkpoint inhibitors, such as antibodies against PD-1 and PD-L1, in patients with lung cancer has increased our expectations for the success of these therapeutics as neoadjuvant immunotherapy. Neoadjuvant therapy is widely used in patients with resectable stage IIIA NSCLC and can reduce primary tumor and lymph node stage, improve the complete resection rate, and eliminate microsatellite foci; however, complete pathological response is rare. Moreover, because the clinical benefit of neoadjuvant therapy is not obvious and may complicate surgery, it has not yet entered the mainstream of clinical treatment. Small-scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancellation of surgery, additional illness, and even death, and have therefore attracted much attention. In this article, we draw on several sources of information, including (i) guidelines on adverse reactions related to immune checkpoint inhibitors, (ii) published data from large-scale clinical studies in thoracic surgery, and (iii) practical experience and published cases, to provide clinical recommendations on adverse events in NSCLC patients induced by perioperative immunotherapy.
A prospective trial of CT-guided percutaneous microwave ablation for lung tumors. [2022]Percutaneous ablation is an alternative treatment for lung cancer in non-operable patients. This is a prospective clinical trial for percutaneous microwave ablation (pMWA) of biopsy-proven lung cancer to demonstrate safety and efficacy.
Microwave Ablation for Malignant Central Airway Obstruction: A Pilot Study. [2022]Malignant central airway obstruction (CAO) is a debilitating complication of primary lung cancer and pulmonary metastases. Therapeutic bronchoscopy is used to palliate symptoms and/or bridge to further therapy. Microwave ablation (MWA) heats tissue by creating an electromagnetic field around an ablation device. We present a pilot study utilizing endobronchial MWA via flexible bronchoscopy as a novel modality for the management of malignant CAO.
The safety and feasibility of three-dimensional visualization planning system for CT-guided microwave ablation of stage I NSCLC (diameter ≤2.5 cm): A pilot study. [2023]Microwave ablation (MWA) of lung tumors is a technique that is dependent on the ablationist's level of expertise. The selection of the optimum puncture path and determination of appropriate ablative parameters is the key to the success and safe of the procedure. The objective of this study was to describe the clinical use of a novel three-dimensional visualization ablation planning system (3D-VAPS) for aided MWA of stage I non-small cell lung cancer (NSCLC).