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

Prior treatment

• Prior definitive treatment for the target pulmonary nodule (e.g., surgical resection, radiotherapy, ablation, or systemic anti-tumor therapy).
• Unstable ART status: not on continuous ART or HIV viral load ≥50 copies/mL within 3 months prior to enrollment.
• Target lesion already diagnosed definitively by previous percutaneous biopsy or surgical pathology.

Other illness

• Active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia requiring acute treatment at the time of screening.
• Severe cardiopulmonary dysfunction:
  • Forced Expiratory Volume in 1 second (FEV1) \<50% predicted; or
  • New York Heart Association (NYHA) Class III-IV heart failure.
• 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).

Lab values

• Coagulation disorder: International Normalized Ratio (INR) \>1.5 or platelet count \<50 × 10\^9/L.

Other

• Pregnancy or breastfeeding.
• Participation in another interventional clinical trial within the past 3 months.
• Inability to complete follow-up (e.g., no fixed residence, unstable contact information).

• Confirmed diagnosis of HIV infection; on stable antiretroviral therapy (ART) for ≥6 months with plasma HIV viral load \<50 copies/mL.
• 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%.
• Age 18-70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Life expectancy ≥6 months.
• Voluntary written informed consent obtained prior to any study procedure; willingness and ability to comply with scheduled visits, procedures, and follow-up requirements.