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

NCT07663656 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-23

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Pulmonary Nodule

Interventions

PROCEDURE

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

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.

PROCEDURE

Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy

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.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    collaborator OTHER

  • Shanghai Chest Hospital

    collaborator OTHER

  • wu qingguo

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-01-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663656 on ClinicalTrials.gov