ENB Guided MWA for Early-stage Peripheral Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients undergoing bronchoscopic MWA 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
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.
|
Outcome Measures
Primary Outcome Measures
- Objective response rate（ORR） [Three months after ablation]
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.
Secondary Outcome Measures
- Arrival rate of the locatable wire [During the procedure]
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.
- Progression-free survival (PFS) [At least 3 months]
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) [From the time of treatment to the time of the patient death with a follow-up period of 5 years]
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
- Complication rate [From the time of treatment to one month after ablation]
Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with peripheral lung nodules demonstrated to be NSCLC by pathology with the clinical stage of IA.
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The length-diameter of the tumors are more than 8 mm and no more than 30 mm.
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Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
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Patients have good compliance and sign the informed consent.
Exclusion Criteria:
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Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
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Patients have contraindications of general anesthesia.
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Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
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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.
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There are large blood vessels or important structures adjacent to peripheral lung lesion.
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Researchers consider the patient do not fit for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Chest Hospital | Shanghai | Shanghai | China | 200030 |
Sponsors and Collaborators
- Shanghai Chest Hospital
Investigators
- Principal Investigator: Jiayuan Sun, MD, PhD, Shanghai Chest Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 2017YFC0112702-MWA