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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Lung Neoplasms; Diagnosis
• Interventions: Diagnostic Test: Cone-Beam CT; Diagnostic Test: Robotic Assisted Bronchoscopy

• Registration Number: NCT06489678
• Lead Sponsor: University of Zurich

Brief Summary

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.

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 Timeline

• Study Start: 2024-06-25
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-10-01
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cone-beam CT	Cone-Beam CT	Usual care with the added option for intraprocedural cone-beam CT (3-dimensional reconstruction of the anatomy, target lesion, and biopsy tools; Cios Spin, Siemens) without any limits on the number of spins, provided the effective dose remains below 5 mSv.
Cone-beam CT and robotic assisted bronchoscopy	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield	Including a 12-month follow-up (clinical data)	ATS 2024 consensus criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland