Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Capability [8 months]
To explore if Deep neural network (DNN) has capability to segment lymph nodes and blood vessels from EBUS images
Secondary Outcome Measures
- Precision [2 months]
The precision the DNN has for detecting lymph nodes and blood vessels. Measured both per voxel in the EBUS images and per annotated structure (a structure is counted as detected if at least 50% of its annotated pixels are identified by the DNN).
- Sensitivity [2 months]
True positive rate. Correctly detected lymph nodes/blood vessel over total lymph nodes/blood vessel. Measured per pixel in the EBUS images
- Specificity [2 months]
Specificity = (True Negative)/(True Negative + False Positive). Measured per pixel in the EBUS images.
- Dice similarity coefficient [2 months]
Measures the similarity between two sets of data: Annotated by pulmonologist vs DNN.
- Run-time [2 months]
Is the run-time sufficiently low for real-time analysis during EBUS?
- Adverse events [48 hours]
Procedure related adverse events or unexpected incidents registered
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects referred to thoracic department in any of the participating hospitals with undiagnosed enlarged mediastinal and hilar lymph nodes.
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Subjects have to be ≥ 18 years of age
Exclusion Criteria:
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Pregnancy
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Any patient that the Investigator feels is not appropriate for this study for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust | Levanger | Norway | 7600 | |
| 2 | Department of Thoracic Medicine, St Olavs Hospital | Trondheim | Norway | 7030 |
Sponsors and Collaborators
- Norwegian University of Science and Technology
- Helse Nord-Trøndelag HF
- SINTEF Health Research
Investigators
- Study Director: Øivind Rognmo, Dr.philos, Norwegian University of Science and Technology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 240245