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RecruitingNCT05739331Updated Sep 30, 2026

Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence

An observational study in Artificial Intelligence, Endobronchial Ultrasound and Lung Cancer, sponsored by Norwegian University of Science and Technology. Recruiting at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Norwegian University of Science and Technology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Artificial Intelligence
  • Endobronchial Ultrasound
  • Lung Cancer

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patents with undiagnosed enlarged mediastinal and hilar lymph nodes who have been recommended for Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA).

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

Exclusion Criteria:

  • Pregnancy
  • Any patient that the Investigator feels is not appropriate for this study for any reason.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Devicemachine learning algorithm

    Machine learning algorithm run on EBUS images for real-time labelling of mediastinal lymph nodes and lymph node level

05

What researchers measure

Primary outcomes

  1. Capability

    To explore if Deep neural network (DNN) has capability to segment lymph nodes and blood vessels from EBUS images

    Time frame: 8 months

Secondary outcomes

  1. 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).

    Time frame: 2 months

  2. Sensitivity

    True positive rate. Correctly detected lymph nodes/blood vessel over total lymph nodes/blood vessel. Measured per pixel in the EBUS images

    Time frame: 2 months

  3. Specificity

    Specificity = (True Negative)/(True Negative + False Positive). Measured per pixel in the EBUS images.

    Time frame: 2 months

  4. Dice similarity coefficient

    Measures the similarity between two sets of data: Annotated by pulmonologist vs DNN.

    Time frame: 2 months

  5. Run-time

    Is the run-time sufficiently low for real-time analysis during EBUS?

    Time frame: 2 months

  6. Adverse events

    Procedure related adverse events or unexpected incidents registered

    Time frame: 48 hours

06

Study locations

2 of 2 sites recruiting
  • Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust
    Levanger, 7600, Norway
    Recruiting
  • Department of Thoracic Medicine, St Olavs Hospital
    Trondheim, 7030, Norway
    Recruiting
07

Registry details

Key details

Study ID
NCT05739331
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF, SINTEF Health Research
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
May 1, 2023
Primary completion
May 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Øyvind Ervik, MD
Contact
oyvind.ervik@ntnu.no
+4791634595
Hanne Sorger, MD,PhD
Contact
hanne.sorger@ntnu.no
+4791816787
Øivind Rognmo, Dr.philos
study director · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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