Bronchoscopic microwave ablation for lung tumors

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

This study will test whether delivering microwave energy through a bronchoscope can safely treat small primary or metastatic lung tumors in adults who cannot or will not have surgery or radiation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06969014 on ClinicalTrials.gov

What this trial studies

This is a single‑site interventional study delivering transbronchial microwave ablation (MWA) under bronchoscopy guidance to peripheral lung tumors. Eligible participants are adults with primary stage IA (T1N0M0) peripheral lung cancer or limited metastatic nodules (≤3 cm and ≤3 lesions) judged reachable by bronchoscopy. Patients enroll after being considered unsuitable for or refusing surgery and radiotherapy, and procedures are performed at Shanghai Chest Hospital. Outcomes will focus on technical success, local tumor control, and procedure‑related safety and complications.

Who should consider this trial

Good fit: Adults (≥18) with a peripheral primary early‑stage lung tumor (T1N0M0, stage IA) or up to three metastatic lung nodules ≤3 cm that are considered reachable by bronchoscopy and who are unsuitable for or decline surgery/radiation.

Not a fit: Patients with diffuse bilateral disease, intrathoracic nodal or extrapulmonary metastases, or lesions that cannot be accessed safely by bronchoscopy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this could offer a minimally invasive local treatment option to control small lung tumors for patients who cannot or choose not to undergo surgery or radiation.

How similar studies have performed: Percutaneous MWA and other bronchoscopic thermal techniques have shown local control for small lung nodules, but transbronchial MWA is an emerging approach with limited published outcome data.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jiayuan Sun

Conditions: Lung Cancer