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Completed

NCT Number: NCT04816981

AI-EBUS-Elastography for LN Staging

Before any treatment decisions are made for patients with lung cancer, it is crucial to determine whether the cancer has spread to the lymph nodes in the chest. Traditionally, this is determined by taking biopsy samples from these lymph nodes, using the Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) procedure. Unfortunately, in 40% of the time, the results of EBUS-TBNA are not informative and wrong treatment decisions are made. There is, therefore, a recognized need for a better way to determine whether the cancer has spread to the lymph nodes in the chest. The investigators believe that elastography, a recently discovered imaging technology, can fulfill this need. In this study, the investigators are proposing to determine whether elastography can diagnose cancer in the lymph nodes. Elastography determines the tissue stiffness in the different parts of the lymph node and generates a colour map, where the stiffest part of the lymph node appears blue, and the softest part appears red. It has been proposed that if a lymph node is predominantly blue, then it contains cancer, and if it is predominantly red, then it is benign. To study this, the investigators have designed an experiment where the lymph nodes are imaged by EBUS-Elastography, and the images are subsequently analyzed by a computer algorithm using Artificial Intelligence. The algorithm will be trained to read the images first, and then predict whether these images show cancer in the lymph node. To evaluate the success of the algorithm, the investigators will compare its predictions to the pathology results from the lymph node biopsies or surgical specimens.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients that are diagnosed with suspected or confirmed NSCLC that have been referred to mediastinal staging through EBUS-TBNA at St. Joseph's Healthcare Hamilton will be eligible for this study.

Exclusion criteria

  • No exclusion criteria will apply.

Treatment and study plan

EBUS-Elastography

Device

Patients undergoing LN staging for lung cancer with EBUS-TBNA will have digital images and biopsy of every LN obtained in accordance with standards of care. Prior to the lymph node biopsy by EBUS-TBNA, elastography will be performed. The relative strain of tissues in the scanned area of the LNs will be displayed as a colour map, with stiffer areas in blue and softer tissue in red. Elastography and B-mode images will be displayed side by side and images recorded and saved onto an external drive for analysis. Elastography images will be fed to the NeuralSeg algorithm which has a network architecture similar to the standard U-Net for image segmentation. The automatically identified regions of interest will be overlaid onto the EBUS Elastography images to extract the LN stiffness measurements. After overlaying, NeuralSeg will determine the proportion of the LN area within 9 previously defined stiffness thresholds.

Primary outcomes

  1. Stiffness Area Ratio

    Time frame: 8 months

    Identifying whether the percent area of a lymph node above a defined blue colour threshold is independently associated with malignancy

Secondary outcomes

  1. NeuralSeg's prediction of lymph node malignancy

    Time frame: 2 months

    Determine whether NeuralSeg can accurately predict malignancy in lymph nodes when compared to biopsy results of the lymph nodes that were examined

  2. The agreement between NeuralSeg's predictions and pathology results, as measured by diagnostic accuracy, sensitivity, specificity, positive and negative predictive values

    Time frame: 2 months

    The agreement between NeuralSeg's predictions and pathology results, as measured by diagnostic accuracy, sensitivity, specificity, positive and negative predictive values

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

Clinical Utility of Artificial Intelligence-Augmented Endobronchial Ultrasound-Elastography in Lymph Node Staging for Lung Cancer

Acronym: AI-EBUS-E

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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