Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

November 30, 2023 updated by: Hangzhou Broncus Medical Co., Ltd.

Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial

The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jiayuan Sun, MD, PhD
  • Phone Number: 1511 86-021-22200000
  • Email: xkyyjysun@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Principal Investigator:
          • Jiayuan Sun, MD, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age greater than 18 years.
  2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
  3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
  4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

Exclusion Criteria:

  1. Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
  2. Patients with severe pulmonary fibrosis and pulmonary hypertension.
  3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
  4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
  5. Patients with poorly controlled malignant pleural effusion.
  6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5~7 days before ablation.
  7. Eastern Cooperative Oncology Group (ECOG) score > 2.
  8. Combined with other tumors with extensive metastasis, expected survival < 6 months.
  9. Patients with episodic psychosis.
  10. Patients with implantable electronic devices (such as pacemaker or defibrillator).
  11. Pregnant women, or patients who have pregnancy plans during the study.
  12. Participation or ongoing participation in another clinical study within the past 30 days.
  13. Other situations that the investigator deems inappropriate to participate in this 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transbronchial group
Subjects receive bronchoscopy-guided RFA and undergo follow-up.
Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
Experimental: Transthoracic group
Subjects receive CT-guided RFA and undergo follow-up.
Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete ablation rate at 6 months after ablation
Time Frame: 6 months
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: Immediately after ablation
It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Immediately after ablation
Complete ablation rate 12 months after ablation
Time Frame: 12 months
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
12 months
Local control rate at 1 year, 2 years and 3 years after ablation
Time Frame: 1 year, 2 years and 3years
It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.
1 year, 2 years and 3years
Progression free survival (PFS)
Time Frame: 3 years
It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
3 years
Overall survival (OS)
Time Frame: 3 years
It is defined as the total time from the ablation to the death of the subject.
3 years
Safety
Time Frame: 12 months
To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Broncus Medical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Chest Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiayuan Sun, MD, PHD, Shanghai Chest Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC-I-RF-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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