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

Recruiting

• Conditions: COPD; Lung Cancers

• Registration Number: NCT07045532
• Lead Sponsor: Shanghai Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam	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	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.

Trial Locations

Locations (1)

Shanghai chest hospital; 🇨🇳 Shanghai, Shanghai, China