Clinical trial · Interventional
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
NCT07521618CI-TRIAL-00107867One-stopnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Confocal Laser Endomicroscopy | — | UNRESOLVED | — |
| Cryoablation | — | UNRESOLVED | — |
| Lung Cancer (Suspected or Confirmed) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Robotic Bronchoscopy System | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One-stop group
- description
- Using RBS, nCLE, r-EBUS, OBCT and ablation
- interventionNames
- Procedure: Ablation
Primary outcomes (1)
- measure
- Integrated completion rate of detection, sampling and treatment
- timeFrame
- Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)
- description
- Integrated completion rate of detection, sampling and treatment= (Number of cases with successful integrated detection, sampling and treatment / Total enrolled cases) × 100% Definition of integrated success: Under the guidance of the bronchial navigation and positioning system, the lesion is confirmed by radial endobronchial ultrasound (r-EBUS) or CBCT; imaging diagnosis is obtained via probe-based confocal laser endomicroscopy (pCLE); qualified tissue samples are successfully collected; and local treatment is completed.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDYou 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
- BACKGROUNDXie 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