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

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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.