Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules (NAVIGATOR)

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs.

The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached.

Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.

Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodules, Solitary
• Intervention / Treatment: Procedure: Virtual bronchoscopic navigation

Detailed Description

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Despite its accuracy and diagnostic yield, this technique is associated with an increased risk of complications, Pneumothorax and severe bleeding are the most frequent complications occurring in up to 27% of cases each.

Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs. The overall rate of pneumothorax after ENB is 4.3%, and bleeding occurs in only 2.8% of cases. The combination of techniques led to an overall increase of the diagnostic yield.

The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached. Detailed clinical data, like the correlation of the diagnostic yield to the specific location of the pulmonary nodule, however, is lacking. In view of the expected lung cancer screening program leading to increasing numbers of especially small pulmonary nodules, this data, however, is considered useful to help to select patients forthe right diagnostic procedure.

Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.

Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Expected results With the VBN procedure a histologie diagnosis of a SPN can be obtained safely with high diagnostic yield. Correlation to detailed clinical data is expected to help selecting patients for this procedure in the future.

In the future add on technique such as confocal laser endomicroscopy and fluorescence molecular endoscopy might further improve identification of the lesion during the procedure. Ultimately, we expect that development of this technique will pave the way to a one-stop-shop approach with rapid on-site evaluation followed by local treatment (e.g. microwave ablation) of the malignant pulmonary nodule.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dirk-Jan Slebos, MD PhD; Phone Number: +31503612357; Email: d.j.slebos@umcg.nl
• Study Contact Backup: Name: Birgitta Hiddinga, MD; Phone Number: +31503612357; Email: b.i.hiddinga@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Recruiting
    • UMCG Groningen
    • Contact: Birgitta Hiddinga, MD; Phone Number: +31503612357; Email: b.i.hiddinga@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients undergoing a Virtual bronchoscopy navigation procedure to assess a solitary pulmonary nodule.

Description

Inclusion Criteria:

• age >18
• pulmonary nodule(s) suspicious for malignancy or metastases of a known primary tumour
• a distinct nodule with a diameter of >6 mm in its largest dimension
• nodule located in the parenchymal tissue >1 cm from the pleura and bronchoscopically accessible through a point of entry
• willing to give informed consent to the procedure.

Exclusion Criteria:

• any contraindication to undergo bronchoscopy
• contraindication for general anaesthesia
• inability to stop anticoagulants or antiplatelets agents according to the UMCG protocol
• childbearing or breastfeeding women
• moderate to seyere pulmonary fibrosis
• severe emphysema with bullae > 5 cm m the vicinity of the target nodule or tunnel.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful diagnostic procedure	Number of procedures with success to access the solitary pulmonary nodule	During procedure

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Dirk-Jan Slebos, MD PhD, UMCG Groningen, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: 202100352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No