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

NCT07045532 | Recruiting

• 1 other identifier: KS(Y)23216
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Lung Cancers

Keywords

MRI; COPD; Lung cancer; ablation

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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

  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;

  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;

  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.

  From enrollment to 3 months post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai chest hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lin Ye, MD

CONTACT

021-62821990; sjtuyl@163.com

Jiayuan Sun, MD, PhD

CONTACT

021-62821990; xkyyjysun@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice dean of the hospital

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 1, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2024-09

Locations

CN (1)