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RecruitingNCT07045532Updated Jul 1, 2025

Assessment the Effectiveness of BTVA in COPD and Ablation in Pulmonary Nodules by Pulmonary MRI

An observational study in COPD and Lung Cancers, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Shanghai Chest Hospital · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • COPD
  • Lung Cancers

Keywords

  • MRI
  • COPD
  • Lung cancer
  • ablation
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 100 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients older than 18 years of age with pulmonary nodules and COPD.

Inclusion criteria

  1. Age >18 years old;
  2. 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;
  3. COPD patients: patients diagnosed with COPD according to the GOLD principle and treated with thermal steam ablation for COPD;
  4. Understand the study and sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Chest CT nodules in patients with pulmonary nodules were pure ground glass nodules;
  2. 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;
  3. severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of ablation surgery;
  4. Patients with severe COPD exacerbation or pneumonia in the past four weeks;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to 6 months post-surgery

  2. 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

    Time frame: From enrollment to 6 months post-surgery

  3. 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

    Time frame: From enrollment to 6 months post-surgery

  4. 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

    Time frame: From enrollment to 6 months post-surgery

  5. 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;

    Time frame: From enrollment to 3 months post-surgery

  6. 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;

    Time frame: From enrollment to 3 months post-surgery

  7. 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.

    Time frame: From enrollment to 3 months post-surgery

07

Study locations

1 of 1 sites recruiting
  • Shanghai chest hospital
    Shanghai, Shanghai Municipality 200030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07045532
Lead sponsor
Shanghai Chest Hospital
Responsible party
Jiayuan Sun (Vice dean of the hospital, Shanghai Chest Hospital) — Principal investigator
First posted
Jul 1, 2025
Start date
Sep 1, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 1, 2025

Study contacts

Lin Ye, MD
Contact
sjtuyl@163.com
021-62821990
Jiayuan Sun, MD, PhD
Contact
xkyyjysun@163.com
021-62821990

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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