Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB.

ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA.

Jiayuan Sun, MD, PhD

Jiayuan Sun, MD,PhD

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.

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.

ENB Guided MWA for Early-stage Peripheral Lung Cancer

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

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.

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.

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.

Overall survival（OS) is evaluated after the treatment of ablation until the patient death.

Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.

Shanghai Chest Hospital

Director, Department of Respiratory Endoscopy

Multiple Pulmonary Nodules

ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

EBUS-GS

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

ENB in the Diagnosis of Peripheral Pulmonary Nodules

Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules

Diagnostic yield is defined as proportion of true positive and true negative.

The operation time includes total operation time,total GS time and total EBUS time

Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation

Air Force Military Medical University, China

Xiangya Hospital of Central South University

Director, Department of Endoscopy

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.

Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.

ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.

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.

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.

ENB Guided RFA for Early-stage Peripheral Lung Cancer

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

Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.

Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ENB Guided MWA for Early-stage Peripheral Lung Cancer	NCT04005157	Lung Cancer	MWA ENB	18 Years -	Shanghai Chest Hospital
ENB in the Diagnosis of Peripheral Pulmonary Nodules	NCT03569306	Peripheral Pulm...	ENB EBUS-GS	18 Years -	Shanghai Chest Hospital
ENB Guided RFA for Early-stage Peripheral Lung Cancer	NCT03009630	Lung Cancer	RFA ENB	18 Years -	Shanghai Chest Hospital
ENB Guided MWA for Early-stage Peripheral Lung Cancer	NCT04005157	Lung Cancer	MWA ENB	18 Years -	Shanghai Chest Hospital
ENB in the Diagnosis of Peripheral Pulmonary Nodules	NCT03569306	Peripheral Pulm...	ENB EBUS-GS	18 Years -	Shanghai Chest Hospital

Spots Global Cancer Trial Database for electromagnetic navigation bronchoscopy(enb)