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NCT Number: NCT07045532

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Cancers Lung Diseases Lung Diseases, Obstructive Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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;

  6. 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;

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayuan Sun, MD, PhD

CONTACT

[email protected]

021-62821990

Lin Ye, MD

CONTACT

[email protected]

021-62821990

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Assessment the Effectiveness of Bronchoscopic Thermal Vapor Ablation in Chronic Obstructive Pulmonary Disease and Ablation in Pulmonary Nodules by Pulmonary Magnetic Resonance Imaging

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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