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

Trial Title: Benefit of Cone-beam CT and Robotic-assisted Bronchoscopy During Bronchoscopy

NCT ID: NCT06489678

Condition: Lung Neoplasms
Diagnosis
Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Disease

Conditions: Keywords:
Cone-beam CT
Robotic assisted Bronchoscopy
Cios Spin
Ion endoluminal System
Advanced Bronchoscopy

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Robotic Assisted Bronchoscopy
Description: 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.
Arm group label: Cone-beam CT and robotic assisted bronchoscopy

Other name: Cios Spin (Siemens) and Ion endoluminal system (Intuitive)

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.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Zurich

Address:
City: Zürich
Zip: 8091
Country: Switzerland

Start date: June 25, 2024

Completion date: July 30, 2027

Lead sponsor:
Agency: University of Zurich
Agency class: Other

Source: University of Zurich

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06489678