About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Any patient that the Investigator feels is not appropriate for this study for any reason.
Trial population
Patents with undiagnosed enlarged mediastinal and hilar lymph nodes who have been recommended for Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA).
Trial design
Case-only
Prospective
Treatments tested in this trial
machine learning algorithm
DeviceMachine learning algorithm run on EBUS images for real-time labelling of mediastinal lymph nodes and lymph node level
Treatment groups
Trial outcomes
Primary outcomes
Capability
To explore if Deep neural network (DNN) has capability to segment lymph nodes and blood vessels from EBUS images
Secondary outcomes
Precision
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
True positive rate. Correctly detected lymph nodes/blood vessel over total lymph nodes/blood vessel. Measured per pixel in the EBUS images
Specificity
Specificity = (True Negative)/(True Negative + False Positive). Measured per pixel in the EBUS images.
Dice similarity coefficient
Measures the similarity between two sets of data: Annotated by pulmonologist vs DNN.
Sponsors and contacts
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Norwegian University of Science and Technology
Lead sponsor
Helse Nord-Trøndelag HF
Collaborator
SINTEF Health Research
Collaborator