COPDNCT07045532
Assessment the Effectiveness of BTVA in COPD and Ablation in Pulmonary Nodules by Pulmonary MRI
An observational study of COPD and Lung Cancers, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
A Clinical Study Based on Magnetic Resonance Imaging of the Lungs to Assess the Efficacy of Thermal Vapor Ablation and Pulmonary Nodule Ablation in Chronic Obstructive Pulmonary Disease After Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Lung Cancers
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients older than 18 years of age with pulmonary nodules and COPD.
Who may be able to join
- Age >18 years old;
- Patients with pulmonary nodules: patients with pulmonary nodules indicated by chest CT, pathologically diagnosed as malignant, and receiving ablative treatment, including transthoracic and percutaneous ablative methods, including radiofrequency, microwave, and freezing;
- COPD patients: patients diagnosed with COPD according to the GOLD principle and treated with thermal steam ablation for COPD;
- Understand the study and sign the informed consent.
Who cannot join
- Chest CT nodules in patients with pulmonary nodules were pure ground glass nodules;
- Patients who install or carry metal implants such as cardiac pacemakers, heart stents, artificial heart valves in the body or suffer from claustrophobia, allergy to contrast media and other reasons are not suitable for MRI examination;
- severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of ablation surgery;
- Patients with severe COPD exacerbation or pneumonia in the past four weeks;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai chest hospital
Shanghai, Shanghai Municipality, 200030
Lin Ye, MD, 021-62821990, sjtuyl@163.com
Jiayuan Sun, MD, PhD, 021-62821990, xkyyjysun@163.com
About this study
Official title: Assessment the Effectiveness of Bronchoscopic Thermal Vapor Ablation in Chronic Obstructive Pulmonary Disease and Ablation in Pulmonary Nodules by Pulmonary Magnetic Resonance Imaging
A Clinical Study Based on Magnetic Resonance Imaging of the Lungs to Assess the Efficacy of Thermal Vapor Ablation and Pulmonary Nodule Ablation in Chronic Obstructive Pulmonary Disease After Surgery.
The efficacy of hot steam ablation for chronic obstructive pulmonary disease was evaluated using the innovative MRI sequence PREFUL_MRI, and the efficacy of pulmonary nodule ablation was evaluated using the innovative MRI sequence GRASP_MRI.
- Conditions
- COPD, Lung Cancers
- Keywords
- MRI, COPD, Lung cancer, ablation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Using the Phase-Resolved Functional Lung(PREFUL)-MRI dedicated post-processing analysis software, we can obtain images of the patient's lung ventilation and perfusion status.
Measured: From enrollment to 6 months post-surgery
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Percentage of perfusion defect (QDP)：Calculation of QDP based on PREFUL-MRI dedicated post-processing software
Measured: From enrollment to 6 months post-surgery
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Percentage of ventilation defect (VDP)：Calculation of VDP based on PREFUL-MRI dedicated post-processing software
Measured: From enrollment to 6 months post-surgery
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Percentage of ventilation-perfusion match (VQM):Calculation of VQM based on PREFUL-MRI dedicated post-processing software
Measured: From enrollment to 6 months post-surgery
Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules
Quantitative parameters of GRASP-MRI images based on the Tofts model:
Volume transfer coefficient(Ktrans)(/min)：the rate transfer constant of gadolinium between plasma and tissue interstitium;
Measured: From enrollment to 3 months post-surgery
Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules
Quantitative parameters of GRASP-MRI images based on the Tofts model:
Interstitial volume(Ve)(0～1)：the extracellular-extravascular volume;
Measured: From enrollment to 3 months post-surgery
Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules
Quantitative parameters of GRASP-MRI images based on the Tofts model:
Kep: Backflow rate constant, reflecting the time constant for returning from EES to the vascular system, Kep = Ktrans / Ve.
Measured: From enrollment to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045532
- Sponsor's protocol ID
- KS(Y)23216
- Status last verified
- Sep 2024
- First submitted
- 4 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Effectiveness of Bronchoscopic Thermal Vapor Ablation in Chronic Obstructive Pulmonary Disease and Ablation in Pulmonary Nodules by Pulmonary Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07045532
- Acronym / sponsor ID
- KS(Y)23216
- Conditions
- COPD, Lung Cancers
- Keywords
- MRI, COPD, Lung cancer, ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
A Clinical Study Based on Magnetic Resonance Imaging of the Lungs to Assess the Efficacy of Thermal Vapor Ablation and Pulmonary Nodule Ablation in Chronic Obstructive Pulmonary Disease After Surgery.
The efficacy of hot steam ablation for chronic obstructive pulmonary disease was evaluated using the innovative MRI sequence PREFUL_MRI, and the efficacy of pulmonary nodule ablation was evaluated using the innovative MRI sequence GRASP_MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age with pulmonary nodules and COPD.
Key inclusion criteria (4 listed)
- Age >18 years old;
- Patients with pulmonary nodules: patients with pulmonary nodules indicated by chest CT, pathologically diagnosed as malignant, and receiving ablative treatment, including transthoracic and percutaneous ablative methods, including radiofrequency, microwave, and freezing;
- COPD patients: patients diagnosed with COPD according to the GOLD principle and treated with thermal steam ablation for COPD;
- Understand the study and sign the informed consent.
Key exclusion criteria (4 listed)
- Chest CT nodules in patients with pulmonary nodules were pure ground glass nodules;
- Patients who install or carry metal implants such as cardiac pacemakers, heart stents, artificial heart valves in the body or suffer from claustrophobia, allergy to contrast media and other reasons are not suitable for MRI examination;
- severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of ablation surgery;
- Patients with severe COPD exacerbation or pneumonia in the past four weeks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Time frame: From enrollment to 6 months post-surgery
Using the Phase-Resolved Functional Lung(PREFUL)-MRI dedicated post-processing analysis software, we can obtain images of the patient's lung ventilation and perfusion status.
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Time frame: From enrollment to 6 months post-surgery
Percentage of perfusion defect (QDP)：Calculation of QDP based on PREFUL-MRI dedicated post-processing software
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Time frame: From enrollment to 6 months post-surgery
Percentage of ventilation defect (VDP)：Calculation of VDP based on PREFUL-MRI dedicated post-processing software
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam
Time frame: From enrollment to 6 months post-surgery
Percentage of ventilation-perfusion match (VQM):Calculation of VQM based on PREFUL-MRI dedicated post-processing software
Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules
Time frame: From enrollment to 3 months post-surgery
Quantitative parameters of GRASP-MRI images based on the Tofts model: Volume transfer coefficient(Ktrans)(/min)：the rate transfer constant of gadolinium between plasma and tissue interstitium;
Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules
Time frame: From enrollment to 3 months post-surgery
Quantitative parameters of GRASP-MRI images based on the Tofts model: Interstitial volume(Ve)(0～1)：the extracellular-extravascular volume;
Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules
Time frame: From enrollment to 3 months post-surgery
Quantitative parameters of GRASP-MRI images based on the Tofts model: Kep: Backflow rate constant, reflecting the time constant for returning from EES to the vascular system, Kep = Ktrans / Ve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Lung Cancers, run by Shanghai Chest Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 1 Jul 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Ye, MD (021-62821990, sjtuyl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam (time frame: From enrollment to 6 months post-surgery). The study lists 7 primary outcomes in all. 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 1 Jul 2025.