Status:
RECRUITING
Transbronchial MWA for Pulmonary Tumors
Lead Sponsor:
Shanghai Chest Hospital
Collaborating Sponsors:
Canyon Medical
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06969014
Start Date
May 12 2025
End Date
April 22 2027
Last Update
July 18 2025
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030