4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / ENB Guided MWA for Early-stage Peripheral Lung Cancer

ENB Guided MWA for Early-stage Peripheral Lung Cancer

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
Lung Cancer Procedure: MWA Device: ENB Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020
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 :
  1. Objective response rate（ORR） [ Time Frame: 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 :
  1. Arrival rate of the locatable wire [ Time Frame: 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.

  2. Progression-free survival (PFS) [ Time Frame: 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.

  3. 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 ]
    Overall survival（OS) is evaluated after the treatment of ablation until the patient death.

  4. Complication rate [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jiayuan Sun, MD, PhD 86-021-22200000 ext 1511 jysun1976@163.com

Locations
Layout table for location information
China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jiayuan Sun, MD,PhD    +86-18017321598    jysun1976@163.com   
Principal Investigator: Jiayuan Sun, MD, PhD         
Sponsors and Collaborators
Shanghai Chest Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jiayuan Sun, MD, PhD Shanghai Chest Hospital
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date January 10, 2020
Actual Study Start Date  ICMJE April 18, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2019) 		Objective response rate（ORR） [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
  • Arrival rate of the locatable wire [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENB Guided MWA for Early-stage Peripheral Lung Cancer
Official Title  ICMJE A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Procedure: MWA
  • Device: ENB
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jiayuan Sun, MD, PhD 86-021-22200000 ext 1511 jysun1976@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005157
Other Study ID Numbers  ICMJE 2017YFC0112702-MWA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiayuan Sun, Shanghai Chest Hospital
Study Sponsor  ICMJE Shanghai Chest Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiayuan Sun, MD, PhD Shanghai Chest Hospital
PRS Account Shanghai Chest Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯