Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV (NCT07663656) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV
100 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Yield
Timeframe: From initial bronchoscopic biopsy through final histopathologic or 12-month imaging confirmation