Transbronchial MWA for Pulmonary Tumors

Официальное название

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

Обзор

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

Вмешательства

• Устройство Microwave ablation
  Microwave ablation of lung tumors

Первичные конечные точки

• Complete ablation rate of main lesion at 6 months post-procedure [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions) [Срок оценки: 12 months]
• Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients) [Срок оценки: 12 months]
• Progression-free survival rate at 12 months post-procedure [Срок оценки: 12 months]
• Overall survival rate at 12 months post-procedure [Срок оценки: 12 months]
• Local progression-free survival rate at 6,12 months post-procedure [Срок оценки: 12 months]
• Technical success rate [Срок оценки: immediately after transbronchial MWA]
• Safety evaluation of medical device use [Срок оценки: immediately after transbronchial MWA]
• ECOG Score [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06969014 · LS25007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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