Clinical trial NCT06489678: Benefit of Cone-beam CT and Robotic-assisted Bronchoscopy During Bronchoscopy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Neoplasms
Diagnosis
Lung Cancer
Keywords: Cone-beam CT
Robotic assisted Bronchoscopy
Cios Spin
Ion endoluminal System
Advanced Bronchoscopy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic Yield
timeFrame: Including a 12-month follow-up (clinical data)
Secondary outcomes:
measure: Radiation exposure
timeFrame: During Intervention
measure: Safety profile
timeFrame: During Intervention
measure: Diagnostic accuracy for milignancy
timeFrame: Including a 12-month follow-up (clinical data)
measure: Quality of biopsies
timeFrame: During Intervention
measure: Navigation success
timeFrame: During Intervention
Other outcomes:
measure: Procedure Duration
timeFrame: During Intervention
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Thomas Gaisl, MD MPH PhD
role: STUDY_DIRECTOR
References: