ENB Guided MWA for Early-stage Peripheral Lung Cancer

Shanghai Chest Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

MWAPROCEDURE

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

ENBDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with peripheral lung nodules demonstrated to be NSCLC by pathology with the clinical stage of IA. 2. The length-diameter of the tumors are more than 8 mm and no more than 30 mm. 3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation. 4. Patients have good compliance and sign the informed consent. Exclusion Criteria: 1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications. 2. Patients have contraindications of general anesthesia. 3. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion. 4. 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. 5. There are large blood vessels or important structures adjacent to peripheral lung lesion. 6. Researchers consider the patient do not fit for the study.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Three months after ablation

Secondary Outcomes

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.

Time frame: 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.

Time frame: At least 3 months

Overall survival (OS)

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

Time frame: 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.

Time frame: From the time of treatment to one month after ablation

Central Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000 jysun1976@163.com

Data from ClinicalTrials.gov

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