Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy

The Benefit of Cone-beam Computed Tomography and Robotic Assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Lesions and Other Lung Disease Requiring Lung Biopsy: An Open-label, Randomized, Controlled Trial.

This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Neoplasms; Lung Cancer; Diagnosis
• Intervention / Treatment: Diagnostic test: Robotic Assisted Bronchoscopy

Detailed Description

This randomized-controlled-trial, classified as Category A under Art 6 ClinO-MD, investigates the potential benefits of integrating cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) into clinical practice for diagnosing pulmonary lesions. The study aims to enhance biopsy accuracy and safety by utilizing 3-dimensional reconstructions and increased flexibility of the bronchoscope tip. It targets two main clinical scenarios: peripheral lung lesions (PPLs) and other lung diseases requiring tissue biopsies. The hypothesis is that CBCT and RAB will significantly improve diagnostic yield compared to traditional 2D fluoroscopy techniques and endobronchial ultrasound.

The trial will involve 300 participants in the overall observational study, with a nested randomized controlled trial (RCT) for specific lesion types, targeting 2x46 lesions for 2 study arms i) usual care, ii) CBCT and RAB .

Primary endpoints include procedure time for the overall trial and diagnostic yield (ATS 2024 criteria) for the nested RCTs, analyzed via Pearson's Chi-squared test and multivariable logistic regression. Inclusion criteria encompass patients aged 18 or older, scheduled for bronchoscopy, with necessary pre-interventional exams and informed consent. Exclusion criteria include inability to tolerate the procedure, pregnancy, previous trial randomization, and specific lung conditions. The study's recruitment phase spans 24 months, with a 12-month follow-up, running from July 2024 to July 2027.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged >18 years
• Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy
• Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy
• Informed consent

Exclusion Criteria:

• Not able to tolerate procedure (bronchoscopy or apnea for CBCT)
• Previous randomization to an arm of the present trial
• Endobronchial lesion causing lobar atelectasis
• Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis)
• Pregnant or lactating women

For nested RCTs (Trial A + B):

• A: At least 1 peripheral lung lesion suspicious for lung cancer, beyond the visual range of the bronchoscope, rounded or irregular opacity, may be well or poorly defined, measuring ≤3 cm in diameter of the short axis (in CT scan)
• B:At least 1 peripheral target lung lesion of any kind beyond the visual range of the bronchoscope (measuring >3 cm in diameter of the short axis and/or with an interstitial pattern)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; For the control arm, standard bronchoscopy (±virtual or electromagnetic navigation, r-EBUS, and 2-dimensional fluoroscopy) will be employed, using various types of bronchoscopes (±ultra-thin bronchoscopes) and biopsy tools (needle, cryoprobe, forceps) at the investigator's discretion.
Active Comparator: Cone-beam CT and robotic assisted bronchoscopy; Usual care with Cone-beam CT and the added option for the use of robotic assisted bronchoscopy (Ion endoluminal System, Intuitive) during the procedure. A connection between the cone-beam CT and the robotic system (NaviLink) is also possible.	Diagnostic test: Robotic Assisted Bronchoscopy; Cone-beam computed tomography (CBCT) technology and robotic-assisted bronchoscopy (RAB) present promising methods to enhance biopsy accuracy and procedural safety through 3-dimensional reconstructions and increased bronchoscope tip flexibility. Additionally, the transfer of navigational data between CBCT and RAB may further improve diagnostic yield. Given their distinct approaches to enhancing diagnostic outcomes, two separate study arms are warranted for CBCT and RAB.; Other Names: Cios Spin (Siemens) and Ion endoluminal system (Intuitive)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield	ATS 2024 consensus criteria	Including a 12-month follow-up (clinical data)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation exposure	Dose area product	During Intervention
Safety profile	Rates of complications (bleeding, pneumothorax, pneumonia)	During Intervention
Diagnostic accuracy for milignancy	True positives + true negatives / true positives + true negatives + false positives + false negatives	Including a 12-month follow-up (clinical data)
Quality of biopsies	Number of malignant cells, suitability rates for further molecular pathological testing	During Intervention
Navigation success	Anatomical confirmation of the position of the catheter in front or within the lesion as confirmed by r-EBUS or CBCT [not fluoroscopy]	During Intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Duration	Time of the whole procedure	During Intervention

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Director: Thomas Gaisl, MD MPH PhD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cone-beam CT; Robotic assisted Bronchoscopy; Cios Spin; Ion endoluminal System; Advanced Bronchoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease
• Other Study ID Numbers: BASEC Nr. 2024-00684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes