Transbronchial MWA for Pulmonary Tumors

Official title

Treatment of Pulmonary Tumors Using Disposable Microwave Ablation Electrodes and a Microwave Ablation System Guided by Bronchoscopy: An Exploratory Study

Overview

The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.

Interventions

• Device Microwave ablation
  Microwave ablation of lung tumors

Primary outcome measures

• Complete ablation rate of main lesion at 6 months post-procedure [Time frame: 6 months]

Secondary outcome measures (8)

• Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions) [Time frame: 12 months]
• Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients) [Time frame: 12 months]
• Progression-free survival rate at 12 months post-procedure [Time frame: 12 months]
• Overall survival rate at 12 months post-procedure [Time frame: 12 months]
• Local progression-free survival rate at 6,12 months post-procedure [Time frame: 12 months]
• Technical success rate [Time frame: immediately after transbronchial MWA]
• Safety evaluation of medical device use [Time frame: immediately after transbronchial MWA]
• ECOG Score [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• Age ≥18 years old;
• Pathologically diagnosed as primary peripheral lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer). Or it is a metastatic lung tumor, the primary lesion has been completely resected, and the maximum diameter of the tumor is ≤3cm, the number of tumors requiring intervention is ≤3.
• The lesion to be ablated has been evaluated as feasible for microwave ablation treatment under bronchoscopy guidance.
• Agree to undergo transbronchial MWA as initial treatment after being assessed unsuitable for surgery and radiotherapy or refusing surgery and radiotherapy, and sign informed consent.

Exclusion criteria

• Diffuse lesions in both lungs, for which ablation therapy is ineffective;
• Preoperative evaluation within one month reveals the presence of intrathoracic lymph node metastasis or extrapulmonary metastasis (excluding cases where extrapulmonary metastasis has been locally controlled);
• Contraindications to bronchoscopy, or inability to tolerate or comply with bronchoscopic procedures;
• Severe hemorrhagic tendency, or uncorrectable coagulation disorders (PT > 18 seconds, PTA < 40%);
• Platelet count < 70 × 10\^9/L, or ongoing anticoagulant and/or antiplatelet therapy that has not been discontinued for more than one week prior to ablation (with the exception of prophylactic low-molecular-weight heparin use);
• Severe pulmonary function impairment, with a maximal ventilatory volume < 40%;
• Concurrent malignancies with widespread metastasis, with an expected survival of less than three months;
• Poor overall condition (including widespread metastasis, severe infection, high fever), infectious or radiation-induced inflammation surrounding the lesion, significant cachexia, severe organ dysfunction, severe anemia, or nutritional and metabolic disturbances that cannot be corrected in the short term;
• Eastern Cooperative Oncology Group (ECOG) performance status score > 2 ;
• Lesions planned for ablation have received radiotherapy within the past six months;
• Active hepatitis B, active hepatitis C, known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive), or other active infections that may impact the patient's ability to undergo treatment as determined by the investigator;
• History of epilepsy, psychiatric disorders, or cognitive impairments;
• Patients with implanted cardiac pacemakers;
• Patients wearing metal jewelry or clothing with metallic components;
• Pregnant or lactating women, and individuals planning to conceive or become pregnant during the study period;
• Participation in any other clinical trial within three months prior to signing the informed consent form (non-interventional studies excluded);
• Any other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06969014 · LS25007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗