One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation

Официальное название

An Exploratory Clinical Trial on the Integration of Detection, Sampling and Treatment of Peripheral Lung Cancer by Robotic Bronchoscopy System

Обзор

Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.

Вмешательства

• Процедура Ablation
  Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer

Первичные конечные точки

• Integrated completion rate of detection, sampling and treatment [Срок оценки: Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)]

Вторичные конечные точки (1)

• Diagnostic success rate [Срок оценки: 3 days after procedure( when the pathological examination results are available)]

Критерии участия

Критерии включения

• Age ≥18 years, male or female.
• High-risk pulmonary nodule/tumor maximum diameter ≤3 cm.
• Lesion judged suitable for bronchial navigation-guided diagnosis and treatment.
• Ineligible for surgery or refuses surgery/radiotherapy; agrees to primary ablation therapy; provides written informed consent.

Критерии исключения

• Diffuse bilateral lung lesions unresponsive to ablation.
• Contraindication to bronchoscopy or inability to tolerate/cooperate with bronchoscopy.
• Severe bleeding tendency or irreversible coagulopathy (PT >18 s, PTA <40%).Platelet count <70×10⁹/L; anticoagulant/antiplatelet therapy discontinued <1 week before ablation (except prophylactic low-molecular-weight heparin).
• Severe pulmonary impairment (maximal voluntary ventilation <40%).
• Other metastatic tumors with widespread metastasis; life expectancy <3 months.
• Poor general condition: widespread metastasis, severe infection, high fever, infectious/radiation inflammation around the lesion, obvious cachexia, severe organ dysfunction, severe anemia, uncorrectable metabolic/nutritional disorders.
• Eastern Cooperative Oncology Group (ECOG) performance status >2.
• Target lesion received radiotherapy within the past 6 months.
• Active hepatitis B, active hepatitis C, known HIV-1/2 antibody positivity, or other active infections judged by the investigator to interfere with treatment.
• History of epilepsy, psychosis, or cognitive impairment.
• Pregnant/lactating females; males or females planning conception during the trial.
• Other conditions deemed inappropriate by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• You Z, Huang J, Wang F, Xu L, Liu J, Li H, Tang J, Li W, Li Z, Liu Y, Bai Y, Li S, Zhong C. Dual-correction robotic bronchoscopy system with ultra-thin catheter for diagnosing challenging peripheral pulmonary nodules: A multi-centre prospective trial. Pulmonology. 2026 Dec;32(1):2621546. doi: 10.1080/25310429.2026.2621546. Epub 2026 Feb 4. PMID 41635252
• Xie F, Zhang Q, Mu C, Zhang Q, Yang H, Mao J, Simoff MJ, Huang J, Zhang X, Sun J. Shape-sensing Robotic-assisted Bronchoscopy (SS-RAB) in Sampling Peripheral Pulmonary Nodules: A Prospective, Multicenter Clinical Feasibility Study in China. J Bronchology Interv Pulmonol. 2024 Aug 8;31(4):e0981. doi: 10.1097/LBR.0000000000000981. eCollection 2024 Oct 1. PMID 39115240

Идентификаторы

NCT: NCT07521618 · CLE-RBS-Ablation · 2022YFC2405200

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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