Transbronchial MWA for Pulmonary Tumors

NCT06969014 | Recruiting

• 1 other identifier: LS25007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Complete ablation rate of main lesion at 6 months post-procedure

  6 months after ablation surgery, the proportion of patients with the main lesion maintained complete ablation among all evaluable patients who received transbronchial microwave ablation treatment.

  6 months

Secondary Outcomes (8)

• Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions)

  12 months

• Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients)

  12 months

• Progression-free survival rate at 12 months post-procedure

  12 months

• Overall survival rate at 12 months post-procedure

  12 months

• Local progression-free survival rate at 6,12 months post-procedure

  12 months

Other Outcomes (1)

• Safety of intervention

  12 months

Study Arms (1)

Transbronchial microwave ablation

EXPERIMENTAL

Device: Microwave ablation

Interventions

Microwave ablation DEVICE

Microwave ablation of lung tumors

Transbronchial microwave ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Canyon Medical: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jiayuan Sun

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice dean of the hospital

Model Details: Transbronchial MWA

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 13, 2025
• Study Start: May 12, 2025
• Primary Completion: April 22, 2026
• Study Completion (Estimated): April 22, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)