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Trial Title:
Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence
NCT ID:
NCT05739331
Condition:
Artificial Intelligence
Endobronchial Ultrasound
Lung Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
machine learning algorithm
Description:
Machine learning algorithm run on EBUS images for real-time labelling of mediastinal
lymph nodes and lymph node level
Summary:
To evaluate the usefulness of Deep neural network (DNN) in the evaluation of mediastinal
and hilar lymph nodes with Endobronchial ultrasound (EBUS). The study will explore the
feasibility of DNN to identify lymph nodes and blood vessel examined with EBUS.
Detailed description:
Multi-center prospective feasibility study. The DNN model will be trained on ultrasound
images with annotation to identifies lymph nodes and blood vessels examined with EBUS.
The ability of the DNN to segment lymph nodes and vessels based on postoperative
processing and static EBUS images will be evaluated in the first part of the study. In
the second part of the study Real-time use of DNN in EBUS procedure will be evaluated.
Criteria for eligibility:
Study pop:
Patents with undiagnosed enlarged mediastinal and hilar lymph nodes who have been
recommended for Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Subjects referred to thoracic department in any of the participating hospitals with
undiagnosed enlarged mediastinal and hilar lymph nodes.
- Subjects have to be ≥ 18 years of age
Exclusion Criteria:
- Pregnancy
- Any patient that the Investigator feels is not appropriate for this study for any
reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust
Address:
City:
Levanger
Zip:
7600
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Øyvind Ervik, MD
Phone:
+4791634595
Email:
oyvind.ervik@ntnu.no
Facility:
Name:
Department of Thoracic Medicine, St Olavs Hospital
Address:
City:
Trondheim
Zip:
7030
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Håkon O Leira, MD, PhD
Phone:
+4799014967
Email:
håkon.o.leira@ntnu.no
Start date:
May 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Norwegian University of Science and Technology
Agency class:
Other
Collaborator:
Agency:
Helse Nord-Trøndelag HF
Agency class:
Other
Collaborator:
Agency:
SINTEF Health Research
Agency class:
Other
Source:
Norwegian University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739331
