ENB Guided MWA for Early-stage Peripheral Lung Cancer

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: ENB; Procedure: MWA

Study type: Interventional

Funder types: Other

Identifiers

NCT04005157

2017YFC0112702-MWA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients undergoing bronchoscopic MWA

Experimental group

Description:

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.

Treatment:

Procedure: MWA

Device: ENB