What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as microwave ablation, radiofrequency ablation, and stereotactic body radiation therapy (SBRT), can have several side effects. These may include pain at the treatment site, fever, and fatigue. There is also a risk of damage to surrounding tissues, which can lead to complications such as pneumothorax (collapsed lung), infection, and bleeding. Additionally, patients may experience transient skin reactions and altered sensations in the treated area. It is important to discuss these potential side effects with a healthcare provider to understand the risks and benefits of the treatment.

What prior FDA approvals exist?

The FDA has approved several advanced treatments for lung cancer, including targeted therapies, immunotherapies, and energy-based ablation techniques. While specific FDA approvals for Transbronchial Microwave Ablation are not detailed, similar energy-based treatments like radiofrequency ablation (RFA) and stereotactic body radiation therapy (SBRT) have been used to target lung tumors. Additionally, immunotherapies such as pembrolizumab and nivolumab, and targeted therapies like osimertinib for EGFR mutations, have been approved to treat advanced non-small cell lung cancer (NSCLC). These treatments aim to improve survival and quality of life for patients with lung cancer.

What other types of research exist?

Promising novel alternatives to Transbronchial Microwave Ablation for lung cancer patients include: 1) Systemic therapy with combination chemotherapy (e.g., cisplatin plus pemetrexed) or immunotherapy (e.g., nivolumab plus ipilimumab) for unresectable cases. 2) Stereotactic Radiosurgery (SRS) for precise targeting of limited metastases. 3) Ablative radiation therapy (RT) for patients with a limited number of metastases. 4) Transarterial Chemoembolization (TACE) combined with other ablative techniques like Radiofrequency Ablation (RFA) or Microwave Ablation (MWA) for comprehensive treatment of metastatic lesions.

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Microwave Ablation

Microwave Ablation for Lung Cancer

N/A

Recruiting

Research Sponsored by Ethicon, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura.

Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG))

Must not have

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month visit

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include discomfort at the procedure site, bleeding, infection risk increase due to probe insertion into the lungs, and potential damage to nearby tissues or organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung tumor is in the outer part of the lung and not near the lung surface.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am 22 years old or older.

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My lung tumor is in the outer part of the lung and not near the lung surface.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had any systemic therapy like chemotherapy in the last 14 days.

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I cannot stop taking my blood thinning medication for 5 days before and up to 3 days after a procedure.

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My lung cancer is located in the large airways.

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I have or might have cancer that has spread to my brain.

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I have had a lung removed.

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I have received radiation therapy to the area planned for ablation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Technique Efficacy

Secondary study objectives

Change in EORTC QLQ-C30

Change in EORTC QLQ-LC13

Change in Pulmonary Function Tests (Diffusion Capacity)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer include surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy. Surgery involves physically removing the tumor, while radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy employs drugs to destroy rapidly dividing cells, and targeted therapy focuses on specific molecular targets associated with cancer. Immunotherapy boosts the body's immune system to fight cancer. Transbronchial Microwave Ablation, similar to the treatment studied in the POWER study, uses microwave energy to generate heat and destroy tumor tissue. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the tumor's characteristics and the patient's overall health, potentially improving outcomes and quality of life.

Trimodality therapy for non-small-cell lung cancer.