Stage IA Lung CancerNCT06052098
Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
A study testing The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system and The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system in people with Stage IA Lung Cancer, run by Hangzhou Broncus Medical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IA Lung Cancer
- What is being tested?
- The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system and The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years.
- Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
Who cannot join
- Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
- Patients with severe pulmonary fibrosis and pulmonary hypertension.
- Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
- 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.
- Patients with poorly controlled malignant pleural effusion.
- 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.
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- Eastern Cooperative Oncology Group (ECOG) score > 2.
- Combined with other tumors with extensive metastasis, expected survival < 6 months.
- Patients with episodic psychosis.
- Patients with implantable electronic devices (such as pacemaker or defibrillator).
- Pregnant women, or patients who have pregnancy plans during the study.
- Participation or ongoing participation in another clinical study within the past 30 days.
- Other situations that the investigator deems inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, MD, PhD, 86-021-22200000 ext. 1511, xkyyjysun@163.com
Jiayuan Sun, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Stage IA Lung Cancer
- Being tested
- The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system, The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation systemDevice
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.
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation systemDevice
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
| Study group | Role | What they receive |
|---|---|---|
| Transbronchial group | Experimental | Subjects receive bronchoscopy-guided RFA and undergo follow-up. Receives: Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system |
| Transthoracic group | Experimental | Subjects receive CT-guided RFA and undergo follow-up. Receives: Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ablation rate at 6 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
Measured: 6 months
Secondary outcomes (6)
Technical success rate
It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Measured: Immediately after ablation
Complete ablation rate 12 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
Measured: 12 months
Local control rate at 1 year, 2 years and 3 years after ablation
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.
Measured: 1 year, 2 years and 3years
Progression free survival (PFS)
It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
Measured: 3 years
Overall survival (OS)
It is defined as the total time from the ablation to the death of the subject.
Measured: 3 years
Safety
To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start11 Oct 2023
- Primary completionApr 2025 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Jiayuan Sun, MD, PhD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052098
- Sponsor's protocol ID
- BC-I-RF-01
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06052098
- Acronym / sponsor ID
- BC-I-RF-01
- Conditions
- Stage IA Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transbronchial group | Experimental | Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation systemSubjects receive bronchoscopy-guided RFA and undergo follow-up. |
| Transthoracic group | Experimental | Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation systemSubjects receive CT-guided RFA and undergo follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years.
- Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
Key exclusion criteria (13 listed)
- Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
- Patients with severe pulmonary fibrosis and pulmonary hypertension.
- Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
- 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.
- Patients with poorly controlled malignant pleural effusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation systemProcedure: 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. | Device | Transbronchial group |
| The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation systemProcedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT. | Device | Transthoracic group |
Primary outcome
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 secondary outcomes
Technical success rate
Time frame: Immediately after ablation
Complete ablation rate 12 months after ablation
Time frame: 12 months
Local control rate at 1 year, 2 years and 3 years after ablation
Time frame: 1 year, 2 years and 3years
Progression free survival (PFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Safety
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiayuan Sun, MD, PhD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system and The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system in people with Stage IA Lung Cancer, run by Hangzhou Broncus Medical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD, PhD (86-021-22200000 ext. 1511, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate at 6 months after ablation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.