Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS

NCT ID: NCT02493023

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-08-31

Brief Summary

Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires optimal sampling precision.Electromagnetic navigation systems are promising for intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy depends largely on correct alignment of preoperative images to the patient´s position in space during endoscopy. In this study, the accuracy of a new fast and automatic image-to-patient registration method during the initial phase of bronchoscopy is assessed in patients referred for lung cancer investigation.

Detailed Description

This is an accuracy study of a new automatic CT-to-patient registration technique for bronchoscopy and endobronchial ultrasound bronchoscopy (EBUS). An in-house research and development navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its exact position in three-dimensional (3D) maps made from the patients' own preoperative CT images. The navigation system is used for acquiring position data from a bronchoscope or EBUS-scope (same sort of output data acquired from both endoscopes in this study) equipped with a position sensor for electromagnetic tracking. From intraoperative position data, the accuracy of the image-to-patient registration and the navigation system accuracy can be calculated. When targeting a certain lymph node or tumor for sampling, the pulmonologist can use electromagnetic navigation combined with preoperative CT images to navigate directly, precisely and accurately to the area of interest. Functional systems for navigated bronchoscopy and EBUS may therefore lead to considerable improvements in lung cancer diagnosis and mediastinal staging.

Conditions

Bronchial Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

navigated bronchoscopy

Group Type: EXPERIMENTAL

navigated bronchoscopy

Intervention Type: DEVICE

Interventions

navigated bronchoscopy

Intervention Type: DEVICE

Other Intervention Names

position tracked bronchoscope; navigated endobronchial ultrasound (EBUS)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

SINTEF Health Research

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toril A Nagelhus Hernes, prof

Role: STUDY_DIRECTOR

Department of Circulation and Imaging

Locations

Department of Thoracic Medicine, St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

Sorger H, Hofstad EF, Amundsen T, Lango T, Leira HO. A novel platform for electromagnetic navigated ultrasound bronchoscopy (EBUS). Int J Comput Assist Radiol Surg. 2016 Aug;11(8):1431-43. doi: 10.1007/s11548-015-1326-7. Epub 2015 Nov 28.

Reference Type: RESULT

PMID: 26615428 (View on PubMed)

Other Identifiers

2010/3385

Identifier Type: -

Identifier Source: org_study_id