ENB Guided RFA 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 radiofrequency ablation (RFA) for the treatment of early-stage peripheral lung cancer.

Detailed Description
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The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a single-center prospective trial with one arm. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study. Fifty patients are expected to be enrolled totally.

Official Title
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The Clinical Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Radiofrequency Ablation (RFA) for the Treatment of Early-stage Peripheral Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: RFA
* Device: ENB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA. The tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 10 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: RFA group<br>Patients with early-stage peripheral lung cancer will be performed RFA with the guidance of ENB. Post treatment response and follow up will be evaluated and carried out according to the standard procedure. | Procedure: RFA<br>* Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.<br>Device: ENB<br>* ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate（ORR）of participants as assessed by the modified RECIST criteria | 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 |
| --- | --- | --- |
| Progression-free survival (PFS) of participants | Disease progression is evaluated by the variation of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria. | From the time of treatment to the time of disease progression or death with a follow-up period of 3 years | 
| Overall survival（OS）of participants | 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 | 

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