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

NCT07521618 | Not Yet Recruiting

• 2 other identifiers: CLE-RBS-Ablation2022YFC2405200
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Cancer (Suspected or Confirmed); Cryoablation; Robotic Bronchoscopy System; Confocal Laser Endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Integrated completion rate of detection, sampling and treatment

  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.

  Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)

Secondary Outcomes (1)

• Diagnostic success rate

  3 days after procedure( when the pathological examination results are available)

Study Arms (1)

One-stop group

EXPERIMENTAL

Using RBS, nCLE, r-EBUS, OBCT and ablation

Procedure: Ablation

Interventions

Ablation PROCEDURE

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

One-stop group

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, 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

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

Changhao Zhong

CONTACT

02081566640; vast1982@126.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: Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03