Transbronchial MWA for Pulmonary Tumors

Launched by SHANGHAI CHEST HOSPITAL · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called transbronchial microwave ablation (MWA) for lung cancer. The goal is to see how effective and safe this method is for patients with specific types of lung tumors. The trial will include adults aged 18 and older who have been diagnosed with certain early-stage lung cancers or metastatic tumors (cancers that have spread from another area) that are small enough to treat. To be eligible, participants should not be suitable for surgery or radiation therapy and must agree to undergo this new treatment.

If you or a loved one qualifies for this trial, you can expect to receive treatment that uses heat to destroy the cancer cells in the lungs. This is done through a bronchoscope, a thin tube that goes into the lungs. It’s important to know that not everyone can participate; for instance, those with more serious health issues, certain infections, or severe lung function problems will not be eligible. The trial is not yet recruiting participants, but it aims to provide valuable information about this treatment option for lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old;
• • 2. 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.
• • 3. The lesion to be ablated has been evaluated as feasible for microwave ablation treatment under bronchoscopy guidance.
• • 4. 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:
• • 1. Diffuse lesions in both lungs, for which ablation therapy is ineffective;
• • 2. 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);
• • 3. Contraindications to bronchoscopy, or inability to tolerate or comply with bronchoscopic procedures;
• • 4. Severe hemorrhagic tendency, or uncorrectable coagulation disorders (PT \> 18 seconds, PTA \< 40%);
• • 5. 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);
• • 6. Severe pulmonary function impairment, with a maximal ventilatory volume \< 40%;
• • 7. Concurrent malignancies with widespread metastasis, with an expected survival of less than three months;
• • 8. 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;
• • 9. Eastern Cooperative Oncology Group (ECOG) performance status score \> 2 ;
• • 10. Lesions planned for ablation have received radiotherapy within the past six months;
• • 11. 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;
• • 12. History of epilepsy, psychiatric disorders, or cognitive impairments;
• • 13. Patients with implanted cardiac pacemakers;
• • 14. Patients wearing metal jewelry or clothing with metallic components;
• • 15. Pregnant or lactating women, and individuals planning to conceive or become pregnant during the study period;
• • 16. Participation in any other clinical trial within three months prior to signing the informed consent form (non-interventional studies excluded);
• • 17. Any other conditions deemed by the investigator as unsuitable for participation in this clinical trial.