Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
Sponsorwu qingguo
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia requiring acute treatment at the time of screening.
Coagulation disorder: International Normalized Ratio (INR) >1.5 or platelet count <50 × 10^9/L.
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.
Trial design
Treatments tested in this trial
- Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy
- Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
wu qingguo
Lead sponsor
Shanghai Public Health Clinical Center
Sponsor institution
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Shanghai Chest Hospital
Collaborator
Source ClinicalTrials.gov