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Completed

NCT Number: NCT02745002

Navigated EBUS and Functional Imaging in Lung Cancer

Electromagnetic navigation systems have proved feasible for precise intraoperative guiding during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA), based on maps made of preoperative CT images. PET--CT, PET--MRI and fMRI can point out malignant lesions.

When fused into a research navigation system, functional imaging can add information of optimal sampling points in lung cancer staging. Correct image registration is then fundamental. This study is a build--on to NCT02493023, assessing the position and image registration accuracy and clinical feasibility of a multimodal image guiding system in patients referred for lung cancer staging by EBUS--TBNA.

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Key information

Conditions

Bronchial Neoplasms Bronchial Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Medicine, St Olavs Hospital

Trondheim, Norway

About this study

A research navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its position in 3D maps made from the patients' own preoperative images (PET-- CT, PET--MRI or fMRI). Images are acquired ahead of study inclusion. The navigation system acquires position data, first from a videobronchoscope, then from an EBUS--scope (same sort of output data acquired from both endoscopes) equipped with a position sensor for electromagnetic tracking.

From intraoperative position data, the accuracy of the image--to--patient registration (for CT, PET--CT, PET--MRI and fMRI) and the navigation system accuracy are calculated.

Electromagnetic navigation fused with available image modalities can be used to navigate directly and precisely to the area with highest suspicion of malignancy. Multimodal image guiding systems with functional imaging may thereby lead to improvements in endoscopic lung cancer staging, f. i. in diagnostic yield, procedure time and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
  • informed consent

Exclusion criteria

  • pregnancy

Treatment and study plan

navigated bronchoscopy

Device

Other names: position tracked bronchoscope, navigated endobronchial ultrasound (EBUS)

Primary outcomes

  1. Endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT, PET-CT, PET-MRI or fMRI images

    Time frame: 48 hours

    intraoperative positional data of bronchoscope or endobronchial ultrasound scope (EBUS) measured and stored in navigation system software, used for registration and navigation system accuracy calculations

Secondary outcomes

  1. duration of procedure

    Time frame: 48 hours

    time from first entry of endoscope through vocal cords to final withdrawal of endoscope

  2. patient reported satisfaction

    Time frame: 2 hours

    enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure

  3. adverse events

    Time frame: 48 hours

    procedure related adverse events or unexpected incidents registrated

  4. Operator reported satisfaction

    Time frame: 48 hours

    Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure

  5. Diagnostic yield

    Time frame: 48 hours

    Diagnostic success per TBNA sample defined as >40 lymphocytes/high power field as reported by rapid onsite cytologist

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology
  • SINTEF Health Research

Registry information

Official study title

Assessment of a Novel, Fast and Automatic CT-to-patient Registration Method During Navigated Bronchoscopy and Endobronchial Ultrasound Bronchoscopy (EBUS)

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2016
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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