ENB Guided MWA for Early-stage Peripheral Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005157
• Other study ID #: 2017YFC0112702-MWA
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: June 2020

Study information

• Verified date: January 2020
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD, PhD
• Phone: 86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During the procedure
Secondary	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.	At least 3 months
Secondary	Overall survival (OS)	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
Secondary	Complication rate	Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.	From the time of treatment to one month after ablation