Back to resultsSafety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
Primary Purpose
Lung Neoplasms, Pulmonary Metastasis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring Lung Neoplasms, Radiofrequency ablation, Pulmonary Metastasis, Primary Pulmonary Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old;
- Planned ablated main lesions are pathologically confirmed and other planned ablated lesions are pathologically confirmed or clinical evaluated as primary NSCLC or pulmonary metastasis, and the primary lesions of lung metastasis subjects has been well controlled;
- Number of unilateral lung lesions: ≤ 3 (excepting for multiple primary lung cancers);
- Each lung lesion in size: ≤3 cm ;
- Subjects refuse surgery or are considered intolerant of surgery;
- Subjects refuse or are considered unsuitable for radiotherapy/chemotherapy, or are non-responders for previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy;
- It is feasible to arrive at the target lesions through bronchus path and carry out ablation operations, assessed by investigators;
- Subjects whose Eastern oncology cooperative group (ECOG) physical state score: ≤3;
- Subjects agree to undergo radiofrequency ablation to treat pulmonary lesions.
Exclusion Criteria:
- Subjects with severe bleeding tendency and irreversible clotting disorders; or subjects who have stopped anticoagulation therapy and/or antiplatelet drugs for less than 7 days before ablation;
- Subjects whose preoperative examination within 1 month shows intrathoracic lymph node or extra-pulmonary metastasis (except for extra-pulmonary metastasis controlled by local therapy);
- Planned ablated lesions have received radiotherapy within past 6 months;
- Subjects with high-risk disease for ablation operation;
- The nearest distance between the tumors and trachea, main bronchial tube, esophagus, aortic arch branch, main pulmonary artery, left and right pulmonary artery and the heart is less than 2cm;
- Subjects who have participated in the last 30 days or is participating in other clinical studies;
- Subjects who are pregnant or have pregnancy plan during the study;
- Subjects with bronchoscopy contraindications;
- Subjects with implantable cardiac pacemakers, implantable defibrillators, or other active implants;
- Subjects with general anesthesia contraindications;
- Subjects with other conditions that need to be excluded as determined by investigators.
Sites / Locations
- The First Hospital of Peking University
- The First Affiliated Hospital of Guangzhou Medical University
- Shanghai Chest Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiofrequency Ablation (RFA)
Arm Description
The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter.
Outcomes
Primary Outcome Measures
Complete ablation rate of main lesions at 6 months
Six months after the overall ablation procedure, the proportion that subjects whose main lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Secondary Outcome Measures
Technical success rate (in terms of ablation operations)
It is defined as the proportion that the ablation operations in which the test device is successfully placed at the target lesion and the device is successfully withdrawn after treatment procedure, account for all ablation operations.
Complete ablation rate at 6 months (in terms of ablation lesions)
Six months after overall ablation procedure, the proportion that lesions completely ablated account for all evaluable lesions that receive radiofrequency ablation.
Complete ablation rate at 6 months (in terms of subjects)
Six months after overall ablation procedure, the proportion that subjects whose all ablation lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Intrapulmonary progression-free survival rate at 6 months
Six months after overall ablation procedure, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.
Complete ablation rate at 12 months (in terms of ablation lesions)
Twelve months after the completion of the overall ablation, the proportion that lesions which maintain completely ablated account for all evaluable lesions that receive radiofrequency ablation.
Complete ablation rate at 12 months (in terms of subjects)
Twelve months after overall ablation procedure, the proportion that subjects whose all ablation lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Intrapulmonary progression-free survival rate at 1 year
Twelve months after the completion of the overall ablation, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.
Overall survival rate (OS) at 1 year
It is defined as the proportion of surviving subjects at 1 year from enrollment.
Quality of life (QoL)
The QoL changes are evaluated according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ C30) assessment scale during the follow-up. The EORCT QLQ C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.
Safety
All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0 (if applicable). Related and possible related AEs and SAEs will be determined and evaluated.
Full Information
NCT ID
NCT04619472
First Posted
November 2, 2020
Last Updated
April 17, 2023
Sponsor
Hangzhou Broncus Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04619472
Brief Title
Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
Official Title
A Multicenter, Single Group Target Value Clinical Study to Evaluate Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Broncus Medical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It is a multicenter, single group target value clinical trial to evaluate the safety and effectiveness of radiofrequency ablation for peripheral lung tumors under the conjunction of the pulmonary radiofrequency ablation system with the disposable pulmonary radiofrequency ablation catheter developed by Hangzhou Broncus Medical Co., Ltd.
Detailed Description
The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter. During the study, eligible subjects will be followed up intraoperatively, 24 hours after operation, before discharge/ 7 days after operation (whichever occurs first), 30 days (±7 days) after operation, 3 months (±7 days) after operation, 6 months (±15 days) after operation, 9 months (±15 days) after operation, and 12 months (±15 days) after operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Pulmonary Metastasis
Keywords
Lung Neoplasms, Radiofrequency ablation, Pulmonary Metastasis, Primary Pulmonary Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency Ablation (RFA)
Arm Type
Experimental
Arm Description
The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter.
Intervention Type
Device
Intervention Name(s)
Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter
Intervention Description
The conjunction of the pulmonary RFA system with the disposable pulmonary RFA catheter developed by Hangzhou Broncus Medical Co., Ltd. is aim to specifically target lung tumors. The ablation catheter is designed to reach the tumor through the bronchial pathway.
Primary Outcome Measure Information:
Title
Complete ablation rate of main lesions at 6 months
Description
Six months after the overall ablation procedure, the proportion that subjects whose main lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Technical success rate (in terms of ablation operations)
Description
It is defined as the proportion that the ablation operations in which the test device is successfully placed at the target lesion and the device is successfully withdrawn after treatment procedure, account for all ablation operations.
Time Frame
Immediately after Each Operation
Title
Complete ablation rate at 6 months (in terms of ablation lesions)
Description
Six months after overall ablation procedure, the proportion that lesions completely ablated account for all evaluable lesions that receive radiofrequency ablation.
Time Frame
Six months
Title
Complete ablation rate at 6 months (in terms of subjects)
Description
Six months after overall ablation procedure, the proportion that subjects whose all ablation lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Time Frame
Six months
Title
Intrapulmonary progression-free survival rate at 6 months
Description
Six months after overall ablation procedure, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.
Time Frame
Six months
Title
Complete ablation rate at 12 months (in terms of ablation lesions)
Description
Twelve months after the completion of the overall ablation, the proportion that lesions which maintain completely ablated account for all evaluable lesions that receive radiofrequency ablation.
Time Frame
Twelve months
Title
Complete ablation rate at 12 months (in terms of subjects)
Description
Twelve months after overall ablation procedure, the proportion that subjects whose all ablation lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Time Frame
Twelve months
Title
Intrapulmonary progression-free survival rate at 1 year
Description
Twelve months after the completion of the overall ablation, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.
Time Frame
Twelve months
Title
Overall survival rate (OS) at 1 year
Description
It is defined as the proportion of surviving subjects at 1 year from enrollment.
Time Frame
Twelve months
Title
Quality of life (QoL)
Description
The QoL changes are evaluated according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ C30) assessment scale during the follow-up. The EORCT QLQ C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.
Time Frame
Twelve months
Title
Safety
Description
All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0 (if applicable). Related and possible related AEs and SAEs will be determined and evaluated.
Time Frame
Twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old;
Planned ablated main lesions are pathologically confirmed and other planned ablated lesions are pathologically confirmed or clinical evaluated as primary NSCLC or pulmonary metastasis, and the primary lesions of lung metastasis subjects has been well controlled;
Number of unilateral lung lesions: ≤ 3 (excepting for multiple primary lung cancers);
Each lung lesion in size: ≤3 cm ;
Subjects refuse surgery or are considered intolerant of surgery;
Subjects refuse or are considered unsuitable for radiotherapy/chemotherapy, or are non-responders for previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy;
It is feasible to arrive at the target lesions through bronchus path and carry out ablation operations, assessed by investigators;
Subjects whose Eastern oncology cooperative group (ECOG) physical state score: ≤3;
Subjects agree to undergo radiofrequency ablation to treat pulmonary lesions.
Exclusion Criteria:
Subjects with severe bleeding tendency and irreversible clotting disorders; or subjects who have stopped anticoagulation therapy and/or antiplatelet drugs for less than 7 days before ablation;
Subjects whose preoperative examination within 1 month shows intrathoracic lymph node or extra-pulmonary metastasis (except for extra-pulmonary metastasis controlled by local therapy);
Planned ablated lesions have received radiotherapy within past 6 months;
Subjects with high-risk disease for ablation operation;
The nearest distance between the tumors and trachea, main bronchial tube, esophagus, aortic arch branch, main pulmonary artery, left and right pulmonary artery and the heart is less than 2cm;
Subjects who have participated in the last 30 days or is participating in other clinical studies;
Subjects who are pregnant or have pregnancy plan during the study;
Subjects with bronchoscopy contraindications;
Subjects with implantable cardiac pacemakers, implantable defibrillators, or other active implants;
Subjects with general anesthesia contraindications;
Subjects with other conditions that need to be excluded as determined by investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
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