HIV InfectionsNCT07663656
Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV
A study testing Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy and Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy in people with HIV Infections and Pulmonary Nodule, run by wu qingguo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections, Pulmonary Nodule
- What is being tested?
- Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy and Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 12Show fewer
- 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).
About this study
Official title: Clinical Application and Promotion of Full-Situational Awareness Bronchoscopic Robot Combined With CBCT-Based Multimodal Image Fusion for the Diagnosis and Management of Pulmonary Nodules in People Living With HIV: A Multicenter Open-Label Controlled Study
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:
Read more
- 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.
Read the detailed description
Background Lung cancer is a leading cause of cancer mortality worldwide. Early detection and differentiation of pulmonary nodules are critical for survival. In people living with HIV (PLWH), pulmonary nodules carry a higher risk of malignancy, yet percutaneous biopsy is often contraindicated due to coagulation abnormalities or immunosuppression, and conventional bronchoscopy yields variable diagnostic rates (30%-70%) for peripheral nodules ≤3 cm. Electromagnetic navigation bronchoscopy (ENB) improves accessibility but lacks real-time intraoperative image feedback, while cone-beam CT (CBCT) provides intraoperative 3D imaging without dynamic fusion to robotic navigation. Existing robotic bronchoscopes improve stability but have limited distal fine control in complex airways.
Preclinical and early clinical data suggest that full-situational awareness bronchoscopic robots (FSABR) integrated with CBCT-based multimodal image fusion can construct a dynamically updated 3D lung model, compensate for respiratory-induced target displacement, and improve tool-in-lesion accuracy and biopsy yield. However, clinical evidence-especially in PLWH-remains lacking.
Study Design
This is a prospective, multicenter, randomized (1:1), open-label, parallel-group controlled trial conducted at Shanghai Public Health Clinical Center and collaborating centers. Eligible PLWH with pulmonary nodules ≤3 cm (malignant risk ≥50% by CT) will be randomly assigned to:
- Experimental arm: FSABR with CBCT-based multimodal image fusion guidance for targeted biopsy;
- Control arm: ENB-guided bronchoscopy with radial endobronchial ultrasound (r-EBUS) localization for targeted biopsy.
In both arms, rapid on-site evaluation (ROSE) will be performed to confirm specimen adequacy. For participants with ROSE-confirmed malignancy meeting predefined anatomic and clinical safety criteria, exploratory transbronchial cryoablation will be performed during the same procedure. This therapeutic component is hypothesis-generating only.
Procedures Peripheral nodules will be localized by intraoperative imaging (CBCT in the experimental arm; r-EBUS in the control arm). Targeted biopsy will be performed using a 1.1-mm cryoprobe (typically 3 freeze-thaw cycles or until adequate tissue is obtained). Cryoablation (3 cycles × 12 min) will be attempted only in ROSE-positive patients with early-stage peripheral lung cancer deemed suitable by the operator. Follow-up includes chest CT at post-procedure day 1 and month 1 for all patients, and additional serial CT at 3, 6, 12, and 24 months for patients undergoing cryoablation, together with HIV virologic monitoring (viral load and CD4 count).
Objectives The primary objective is to compare the diagnostic yield (proportion of cases with a definitive benign or malignant histocytologic diagnosis) between the FSABR-CBCT arm and the ENB-r-EBUS arm. Secondary objectives include: tool-in-lesion rate, nodule visualization rate, ROSE adequacy, specimen quality, procedural times, safety (pneumothorax, bleeding, infection, HIV-related events), and feasibility/safety of same-session cryoablation. Sensitivity, specificity, positive and negative predictive values, and accuracy for malignancy will also be calculated using final histopathology or 6-12-month imaging follow-up as reference standard.
This study is expected to provide evidence on the clinical utility of full-situational awareness robotic bronchoscopy with intraoperative CBCT fusion in a vulnerable population and to explore the feasibility of a "diagnose-and-treat" strategy for early lung cancer in PLWH.
- Conditions
- HIV Infections, Pulmonary Nodule
- Being tested
- Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy, Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy
- Keywords
- Full-Situational Awareness Robotic Bronchoscopy, Cone-Beam CT, HIV, Pulmonary Nodule, Cryoablation, Diagnostic Yield
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsyProcedure or 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 cryobiopsyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Procedure: Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy |
| Arm 2 | Active comparator | Not described Receives: Procedure: Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initial bronchoscopic biopsy through final histopathologic or 12-month imaging confirmation
Secondary outcomes (8)
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).
Measured: Intraoperative (at time of biopsy attempt)
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.
Measured: Intraoperative
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).
Measured: Intraoperative
Qualified Cryobiopsy Specimen Rate
Proportion of cryobiopsy specimens meeting predefined quality criteria (length ≥5 mm and containing ≥3 cohesive cell clusters).
Measured: Intraoperative (immediate pathologic assessment)
Cryoablation Success (Exploratory)
Among ROSE-confirmed malignant cases deemed eligible for ablation, proportion in which the cryoprobe is successfully positioned and 3 ablation cycles (12 minutes each) are completed without premature termination due to complication or technical failure.
Measured: Intraoperative
Complete / Partial Ablation Response Rate
Proportion of cryoablated lesions showing complete absorption, fibrosis, or ≥50% size reduction on follow-up HRCT at 6 and 12 months. Assessed only in patients who underwent cryoablation.
Measured: 6 months and 12 months post-procedure
Procedure Time
Time from bronchoscope insertion to removal (total), and separately recorded: navigation time, biopsy time, and cryoablation time (if performed).
Measured: Intraoperative
Safety - Overall Adverse Event Rate
Incidence of pneumothorax, bleeding (graded mild/moderate/severe), pneumonia/fever, air embolism, and HIV-related events (viral load rebound >50 copies/mL or CD4 drop). Severity and relationship to procedure will be assessed per protocol.
Measured: From procedure through 30 days post-procedure (through 24 months for ablated patients regarding delayed complications)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wu qingguo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, wu qingguo, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663656
- Sponsor's protocol ID
- SPHCC-FSABR-CBCT-HIVPN-OC-2026
- Other IDs
- SHDC12025140
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application and Promotion of Full-Situational Awareness Bronchoscopic Robot Combined With CBCT-Based Multimodal Image Fusion for the Diagnosis and Management of Pulmonary Nodules in People Living With HIV: A Multicenter Open-Label Controlled Study
- ClinicalTrials.gov ID
- NCT07663656
- Acronym / sponsor ID
- SPHCC-FSABR-CBCT-HIVPN-OC-2026
- Conditions
- HIV Infections, Pulmonary Nodule
- Keywords
- Full-Situational Awareness Robotic Bronchoscopy, Cone-Beam CT, HIV, Pulmonary Nodule, Cryoablation, Diagnostic Yield
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- wu qingguoOther government
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Lung cancer is a leading cause of cancer mortality worldwide. Early detection and differentiation of pulmonary nodules are critical for survival. In people living with HIV (PLWH), pulmonary nodules carry a higher risk of malignancy, yet percutaneous biopsy is often contraindicated due to coagulation abnormalities or immunosuppression, and conventional bronchoscopy yields variable diagnostic rates (30%-70%) for peripheral nodules ≤3 cm. Electromagnetic navigation bronchoscopy (ENB) improves accessibility but lacks real-time intraoperative image feedback, while cone-beam CT (CBCT) provides intraoperative 3D imaging without dynamic fusion to robotic navigation. Existing robotic bronchoscopes improve stability but have limited distal fine control in complex airways.
Preclinical and early clinical data suggest that full-situational awareness bronchoscopic robots (FSABR) integrated with CBCT-based multimodal image fusion can construct a dynamically updated 3D lung model, compensate for respiratory-induced target displacement, and improve tool-in-lesion accuracy and biopsy yield. However, clinical evidence-especially in PLWH-remains lacking.
Study Design
This is a prospective, multicenter, randomized (1:1), open-label, parallel-group controlled trial conducted at Shanghai Public Health Clinical Center and collaborating centers. Eligible PLWH with pulmonary nodules ≤3 cm (malignant risk ≥50% by CT) will be randomly assigned to:
- Experimental arm: FSABR with CBCT-based multimodal image fusion guidance for targeted biopsy;
- Control arm: ENB-guided bronchoscopy with radial endobronchial ultrasound (r-EBUS) localization for targeted biopsy.
In both arms, rapid on-site evaluation (ROSE) will be performed to confirm specimen adequacy. For participants with ROSE-confirmed malignancy meeting predefined anatomic and clinical safety criteria, exploratory transbronchial cryoablation will be performed during the same procedure. This therapeutic component is hypothesis-generating only.
Procedures Peripheral nodules will be localized by intraoperative imaging (CBCT in the experimental arm; r-EBUS in the control arm). Targeted biopsy will be performed using a 1.1-mm cryoprobe (typically 3 freeze-thaw cycles or until adequate tissue is obtained). Cryoablation (3 cycles × 12 min) will be attempted only in ROSE-positive patients with early-stage peripheral lung cancer deemed suitable by the operator. Follow-up includes chest CT at post-procedure day 1 and month 1 for all patients, and additional serial CT at 3, 6, 12, and 24 months for patients undergoing cryoablation, together with HIV virologic monitoring (viral load and CD4 count).
Objectives The primary objective is to compare the diagnostic yield (proportion of cases with a definitive benign or malignant histocytologic diagnosis) between the FSABR-CBCT arm and the ENB-r-EBUS arm. Secondary objectives include: tool-in-lesion rate, nodule visualization rate, ROSE adequacy, specimen quality, procedural times, safety (pneumothorax, bleeding, infection, HIV-related events), and feasibility/safety of same-session cryoablation. Sensitivity, specificity, positive and negative predictive values, and accuracy for malignancy will also be calculated using final histopathology or 6-12-month imaging follow-up as reference standard.
This study is expected to provide evidence on the clinical utility of full-situational awareness robotic bronchoscopy with intraoperative CBCT fusion in a vulnerable population and to explore the feasibility of a "diagnose-and-treat" strategy for early lung cancer in PLWH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsyParticipants 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 or surgery | Arm 1 |
| Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsyParticipants 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. | Procedure or surgery | Arm 2 |
Primary outcome
Diagnostic Yield
Time frame: From initial bronchoscopic biopsy through final histopathologic or 12-month imaging confirmation
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.
8 secondary outcomes
Tool-in-Lesion Rate
Time frame: Intraoperative (at time of biopsy attempt)
Nodule Visualization Rate
Time frame: Intraoperative
ROSE Adequacy
Time frame: Intraoperative
Qualified Cryobiopsy Specimen Rate
Time frame: Intraoperative (immediate pathologic assessment)
Cryoablation Success (Exploratory)
Time frame: Intraoperative
Complete / Partial Ablation Response Rate
Time frame: 6 months and 12 months post-procedure
Procedure Time
Time frame: Intraoperative
Safety - Overall Adverse Event Rate
Time frame: From procedure through 30 days post-procedure (through 24 months for ablated patients regarding delayed complications)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy and Electromagnetic navigation bronchoscopy with radial EBUS and targeted cryobiopsy in people with HIV Infections and Pulmonary Nodule, run by wu qingguo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: From initial bronchoscopic biopsy through final histopathologic or 12-month imaging confirmation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.