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Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV

Not Yet RecruitingNA

Sponsor: wu qingguo

Conditions: HIV Infections, Pulmonary Nodule

Interventions: Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy, Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy

This multicenter study evaluates a full-situational awareness robotic bronchoscopy system combined with CBCT-based multimodal image fusion for diagnosing lung nodules in people living with HIV (PLWH). Lung nodules are small lesions that may be benign or cancerous. In PLWH, accurate diagnosis is especially important but challenging. In this study, participants will be assigned to one of two groups: * Experimental group: Robotic bronchoscopy with real-time full-situational awareness and CBCT image fusion; * Control group: Electromagnetic navigation-guided bronchoscopy combined with radial endobronchial ultrasound (EBUS). In both groups, rapid on-site cytologic evaluation (ROSE) will be performed to confirm tissue adequacy. For participants confirmed to have lung cancer and meeting safety criteria, an exploratory transbronchial cryoablation will be performed during the same procedure. The study aims to compare diagnostic accuracy and safety between the two approaches and to explore the feasibility of immediate cryoablation for early-stage lung cancer in PLWH.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Confirmed diagnosis of HIV infection; on stable antiretroviral therapy (ART) for ≥6 months with plasma HIV viral load \<50 copies/mL.
2. Presence of at least one pulmonary nodule ≤3 cm in maximum diameter on thin-section CT; radiological features suggestive of malignancy (e.g., part-solid or solid nodule with spiculation, lobulation, or vessel convergence) with estimated pretest probability of malignancy ≥50%.
3. Age 18-70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Life expectancy ≥6 months.
6. Voluntary written informed consent obtained prior to any study procedure; willingness and ability to comply with scheduled visits, procedures, and follow-up requirements.

Exclusion Criteria:

1. Active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia requiring acute treatment at the time of screening.
2. Coagulation disorder: International Normalized Ratio (INR) \>1.5 or platelet count \<50 × 10\^9/L.
3. Prior definitive treatment for the target pulmonary nodule (e.g., surgical resection, radiotherapy, ablation, or systemic anti-tumor therapy).
4. Unstable ART status: not on continuous ART or HIV viral load ≥50 copies/mL within 3 months prior to enrollment.
5. Target lesion already diagnosed definitively by previous percutaneous biopsy or surgical pathology.
6. Severe cardiopulmonary dysfunction:

* Forced Expiratory Volume in 1 second (FEV1) \<50% predicted; or
* New York Heart Association (NYHA) Class III-IV heart failure.
7. Pregnancy or breastfeeding.
8. Participation in another interventional clinical trial within the past 3 months.
9. Inability to complete follow-up (e.g., no fixed residence, unstable contact information).
10. Any other condition that, in the investigator's judgment, would make the participant unsuitable for enrollment or pose unacceptable risk (including significant airway abnormality preventing safe navigation).