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ENB Guided MWA for Early-stage Peripheral Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MWA
ENB
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Electromagnetic navigation bronchoscopy(ENB), Microwave ablation, Peripheral lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing bronchoscopic MWA

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Overall survival (OS)
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
Complication rate
Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.

Full Information

First Posted
June 20, 2019
Last Updated
January 7, 2020
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04005157
Brief Title
ENB Guided MWA for Early-stage Peripheral Lung Cancer
Official Title
A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Electromagnetic navigation bronchoscopy(ENB), Microwave ablation, Peripheral lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing bronchoscopic MWA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MWA
Intervention Description
Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB.
Intervention Type
Device
Intervention Name(s)
ENB
Intervention Description
ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA.
Primary Outcome Measure Information:
Title
Objective response rate（ORR）
Description
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.
Time Frame
Three months after ablation
Secondary Outcome Measure Information:
Title
Arrival rate of the locatable wire
Description
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.
Time Frame
During the procedure
Title
Progression-free survival (PFS)
Description
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.
Time Frame
At least 3 months
Title
Overall survival (OS)
Description
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
Time Frame
From the time of treatment to the time of the patient death with a follow-up period of 5 years
Title
Complication rate
Description
Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.
Time Frame
From the time of treatment to one month after ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, MD, PhD
Phone
86-021-22200000
Ext
1511
Email
jysun1976@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD,PhD
Phone
+86-18017321598
Email
jysun1976@163.com
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28683443
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.
Results Reference
background
PubMed Identifier
24965604
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.
Results Reference
background
PubMed Identifier
26044954
Citation
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.
Results Reference
background
PubMed Identifier
23870347
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.
Results Reference
background
PubMed Identifier
21377589
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.
Results Reference
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ENB Guided MWA for Early-stage Peripheral Lung Cancer

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