ENB Guided MWA for Early-stage Peripheral Lung Cancer

NCT04005157 | Unknown

• 1 other identifier: 2017YFC0112702-MWA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Electromagnetic navigation bronchoscopy(ENB); Microwave ablation; Peripheral lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Arrival rate of the locatable wire

  During the procedure

• Progression-free survival (PFS)

  At least 3 months

• Overall survival (OS)

  From the time of treatment to the time of the patient death with a follow-up period of 5 years

• Complication rate

  From the time of treatment to one month after ablation

Study Arms (1)

Patients undergoing bronchoscopic MWA

EXPERIMENTAL

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; Device: ENB

Interventions

MWA PROCEDURE

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

Patients undergoing bronchoscopic MWA

ENB DEVICE

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

Patients undergoing bronchoscopic MWA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (5)

• Xie F, Zheng X, Xiao B, Han B, Herth FJF, Sun J. Navigation Bronchoscopy-Guided Radiofrequency Ablation for Nonsurgical Peripheral Pulmonary Tumors. Respiration. 2017;94(3):293-298. doi: 10.1159/000477764. Epub 2017 Jul 6.

  PMID: 28683443 BACKGROUND

• Yang X, Ye X, Zheng A, Huang G, Ni X, Wang J, Han X, Li W, Wei Z. Percutaneous microwave ablation of stage I medically inoperable non-small cell lung cancer: clinical evaluation of 47 cases. J Surg Oncol. 2014 Nov;110(6):758-63. doi: 10.1002/jso.23701. Epub 2014 Jun 25.

  PMID: 24965604 BACKGROUND

• Koizumi T, Tsushima K, Tanabe T, Agatsuma T, Yokoyama T, Ito M, Kanda S, Kobayashi T, Yasuo M. Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration. 2015;90(1):47-55. doi: 10.1159/000430825. Epub 2015 May 30.

  PMID: 26044954 BACKGROUND

• Liu H, Steinke K. High-powered percutaneous microwave ablation of stage I medically inoperable non-small cell lung cancer: a preliminary study. J Med Imaging Radiat Oncol. 2013 Aug;57(4):466-74. doi: 10.1111/1754-9485.12068. Epub 2013 May 8.

  PMID: 23870347 BACKGROUND

• Sonntag PD, Hinshaw JL, Lubner MG, Brace CL, Lee FT Jr. Thermal ablation of lung tumors. Surg Oncol Clin N Am. 2011 Apr;20(2):369-87, ix. doi: 10.1016/j.soc.2010.11.008.

  PMID: 21377589 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 2, 2019
• Study Start: April 18, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)