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

NCT07663656 | Not Yet Recruiting

• 2 other identifiers: SPHCC-FSABR-CBCT-HIVPN-OC-2026SHDC12025140
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Full-Situational Awareness Robotic Bronchoscopy; Cone-Beam CT; HIV; Pulmonary Nodule; Cryoablation; Diagnostic Yield

Outcome Measures

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.

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

Secondary Outcomes (8)

• Tool-in-Lesion Rate

  Intraoperative (at time of biopsy attempt)

• Nodule Visualization Rate

  Intraoperative

• ROSE Adequacy

  Intraoperative

• Qualified Cryobiopsy Specimen Rate

  Intraoperative (immediate pathologic assessment)

• Cryoablation Success (Exploratory)

  Intraoperative

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

ACTIVE COMPARATOR

Procedure: Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy

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.

Arm 1

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.

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Target lesion already diagnosed definitively by previous percutaneous biopsy or surgical pathology.
• Severe cardiopulmonary dysfunction:
• Forced Expiratory Volume in 1 second (FEV1) \<50% predicted; or
• New York Heart Association (NYHA) Class III-IV heart failure.
• Pregnancy or breastfeeding.
• Participation in another interventional clinical trial within the past 3 months.
• Inability to complete follow-up (e.g., no fixed residence, unstable contact information).
• Any other condition that, in the investigator's judgment, would make the participant unsuitable for enrollment or pose unacceptable risk (including significant airway abnormality preventing safe navigation).

Sponsors & Collaborators

• wu qingguo: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Shanghai Chest Hospital: collaborator

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Pulmonary Medicine, Shanghai Public Health Clinical Center

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share