ENB Guided MWA for Early-stage Peripheral Lung Cancer

Study Overview
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Brief Summary
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The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided microwave ablation (MWA) for the treatment of early-stage peripheral lung cancer.

Detailed Description
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The study is designed as a multi-center prospective trial with one arm. There will be 5 centers participating the study. Patients diagnosed with early-stage non-small cell lung cancer (NSCLC) that are nonsurgical candidate will be enrolled in the study. Sixty patients are expected to be enrolled in the study. The purpose of the study is to evaluate the efficacy and safety of ENB guided MWA for the treatment of patients with early-stage nonsurgical NSCLC.

Official Title
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A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: MWA
* Device: ENB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peripheral lung nodules demonstrated to be NSCLC by pathology with the clinical stage of IA. The length-diameter of the tumors are more than 8 mm and no more than 30 mm. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation. Patients have good compliance and sign the informed consent. Exclusion Criteria: Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications. Patients have contraindications of general anesthesia. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion. There are large blood vessels or important structures adjacent to peripheral lung lesion. Researchers consider the patient do not fit for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing bronchoscopic MWA<br>Patients meeting the inclusion criteria will be enrolled in the study and undergo ENB guided MWA. Chest CT will be performed at 1 day after the procedure to confirm the complications and then at 1 month, every 3 months for 2 years, and every 6 months for 3 years thereafter after the procedure. PET/CT will be performed 3 months after MWA to assess the treatment response. | Procedure: MWA<br>* Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB.<br>Device: ENB<br>* ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate（ORR） | Tumor response will be evaluated at 3 months after ablation. Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria. | Three months after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrival rate of the locatable wire | Disease progression is evaluated based on the changes of the tumor on computed The arrival rate is the proportion of the locatable wire reaching the location of the tumor accurately. | During the procedure | 
| Progression-free survival (PFS) | Disease progression is evaluated based on the changes of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria. | At least 3 months | 
| Overall survival (OS) | Overall survival（OS) is evaluated after the treatment of ablation until the patient death. | From the time of treatment to the time of the patient death with a follow-up period of 5 years | 
| Complication rate | Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection. | From the time of treatment to one month after ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic navigation bronchoscopy(ENB), Microwave ablation, Peripheral lung cancer