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

ConditionsHIV InfectionsPulmonary Nodule
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy

    Procedure/Surgery

    Participants undergo peripheral pulmonary nodule biopsy using a full-situational awareness bronchoscopic robot. Intraoperative cone-beam CT (CBCT) and multimodal image fusion are used for real-time navigation. ROSE is performed. If ROSE confirms malignancy and safety criteria are met, exploratory transbronchial cryoablation is done in the same session. If robotic navigation fails to obtain a definitive diagnosis, percutaneous transthoracic needle biopsy (PTNB) may be used as rescue.

  • Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy

    Procedure/Surgery

    Participants undergo peripheral pulmonary nodule biopsy using electromagnetic navigation bronchoscopy (ENB) with radial endobronchial ultrasound (r-EBUS) localization. ROSE is performed. If ROSE confirms malignancy and safety criteria are met, exploratory transbronchial cryoablation is done in the same session. If ENB-rEBUS fails to obtain a definitive diagnosis, percutaneous transthoracic needle biopsy (PTNB) may be used as rescue.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic Yield

Proportion of participants from whom a definitive benign or malignant diagnosis is established by histopathology (tissue or ROSE-guided cytology) or, for presumed benign lesions, by stable imaging on 6- to 12-month follow-up. Cases with inadequate specimen or indeterminate pathology are counted in the denominator but not as diagnostic successes.

Time frame
From initial bronchoscopic biopsy through final histopathologic or 12-month imaging confirmation

Secondary outcomes

1

Tool-in-Lesion Rate

Proportion of cases in which the biopsy/cryoprobe tip is confirmed to be within or in direct contact with the target pulmonary nodule by intraoperative imaging (CBCT in the experimental arm; r-EBUS in the control arm).

Time frame
Intraoperative (at time of biopsy attempt)
2

Nodule Visualization Rate

Proportion of target nodules clearly visualized intraoperatively: by CBCT in the robotic arm; by "bull's-eye" or "snowstorm" sign on r-EBUS in the control arm.

Time frame
Intraoperative
3

ROSE Adequacy

Proportion of first biopsy specimens judged as adequate (presence of atypical/suspicious/malignant cells or definitive benign elements) by rapid on-site cytologic evaluation (ROSE).

Time frame
Intraoperative
4

Qualified Cryobiopsy Specimen Rate

Proportion of cryobiopsy specimens meeting predefined quality criteria (length ≥5 mm and containing ≥3 cohesive cell clusters).

Time frame
Intraoperative (immediate pathologic assessment)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

wu qingguo

Lead sponsor

Shanghai Public Health Clinical Center

Sponsor institution

Shanghai Pulmonary Hospital, Shanghai, China

Collaborator

Shanghai Chest Hospital

Collaborator

Source ClinicalTrials.gov

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