Clinical trial NCT06969014: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Canyon Medical
First posted: 2025-05-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Transbronchial MWA
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Complete ablation rate of main lesion at 6 months post-procedure
timeFrame: 6 months
Secondary outcomes:
measure: Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions)
timeFrame: 12 months
measure: Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients)
timeFrame: 12 months
measure: Progression-free survival rate at 12 months post-procedure
timeFrame: 12 months
measure: Overall survival rate at 12 months post-procedure
timeFrame: 12 months
measure: Local progression-free survival rate at 6,12 months post-procedure
timeFrame: 12 months
measure: Technical success rate
timeFrame: immediately after transbronchial MWA
measure: Safety evaluation of medical device use
timeFrame: immediately after transbronchial MWA
measure: ECOG Score
timeFrame: 12 months
Other outcomes:
measure: Safety of intervention
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: