ENB Guided MWA for Early-stage Peripheral Lung Cancer
January 7, 2020 updated by: Jiayuan Sun, Shanghai Chest Hospital
A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Chest Hospital
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Contact:
- Jiayuan Sun, MD,PhD
- Phone Number: +86-18017321598
- Email: jysun1976@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB.
ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective response rate（ORR）
Time Frame: Three months after ablation
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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.
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Three months after ablation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arrival rate of the locatable wire
Time Frame: During the procedure
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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.
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During the procedure
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Progression-free survival (PFS)
Time Frame: At least 3 months
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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.
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At least 3 months
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Overall survival (OS)
Time Frame: From the time of treatment to the time of the patient death with a follow-up period of 5 years
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Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
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From the time of treatment to the time of the patient death with a follow-up period of 5 years
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Complication rate
Time Frame: From the time of treatment to one month after ablation
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Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.
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From the time of treatment to one month after ablation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiayuan Sun, MD, PHD, Shanghai Chest Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2018
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
June 20, 2019
First Submitted That Met QC Criteria
June 30, 2019
First Posted (Actual)
July 2, 2019
Study Record Updates
Last Update Posted (Actual)
January 10, 2020
Last Update Submitted That Met QC Criteria
January 7, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017YFC0112702-MWA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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