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

Conditions

• HIV Infections
• Pulmonary Nodule

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Jun 23, 2026

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Jan 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Outcome Measure

Diagnostic Yield [ Time Frame: From initial bronchoscopic biopsy through final histopathologic or 12-month imaging confirmation ]

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