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The Use of Artificial Intelligence to Predict Cancerous Lymph Nodes for Lung Cancer Staging During Ultrasound Imaging

Development and Validation of a Computer-aided Algorithm Using Artificial Intelligence and Deep Neural Networks for the Segmentation of Ultrasonographic Features of Lymph Nodes During Endobronchial Ultrasound

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03849040
Enrollment
52
Registered
2019-02-21
Start date
2019-04-08
Completion date
2019-11-20
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Lung Neoplasm

Keywords

endobronchial ultrasound, ultrasonographic features, artificial intelligence, deep neural network, segmentation

Brief summary

This study aims to determine if a deep neural artificial intelligence (AI) network (NeuralSeg) can learn how to assign the Canada Lymph Node Score to lymph nodes examined by endobronchial ultrasound transbronchial needle aspiration(EBUS-TBNA), using the technique of segmentation. Images will be created from 300 lymph nodes videos from a prospective library and will be used as a derivation set to develop the algorithm. An additional100 lymph node images will be prospectively collected to validate if NeuralSeg can correctly apply the score.

Interventions

All patients will undergo EBUS-TBNA as per routine care, except for the one difference where the procedures will be video-recorded so that they can be used for computer analysis at a later time. Static images will be obtained from EBUS videos in order to perform segmentation. Segmentation will be conducted by both an experienced endoscopist and NeuralSeg.

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* must be diagnosed with confirmed or suspected lung cancer and be undergoing EBUS diagnosis/staging

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Development of computer algorithm to identify lymph node ultrasonographic featuresFrom retrospective data collection to algorithm development (1 month)Objective: to determine whether a deep neural AI network (NeuralSeg) can learn how to assign the Canada Lymph Node Score to lymph nodes examined by EBUS, using the technique of segmentation on an existing (derivation) set of lymph node videos
Validation of computer algorithm to identify lymph node ultrasonographic featuresFrom prospective data collection to algorithm validation (6 months)Objective: to determine whether NeuralSeg can correctly apply the Canada Lymph Node Score to a new (validation) set of lymph node videos that it has never seen before

Secondary

MeasureTime frameDescription
Accuracy and reliability of the segmentation performed by NeuralSegFrom segmentation performed by surgeon to segmentation performed by NeuralSeg (1 month)Objective: to compare the accuracy and reliability of the segmentation performed by NeuralSeg to the segmentation performed by an experienced endoscopic surgeon using DICE-SORENSEN coefficients.
NeuralSeg prediction of lymph node malignancyFrom NeuralSeg algorithm used on EBUS imaging to biopsy report (estimated up to 2-3 months)Objective: to determine whether NeuralSeg can accurately predict malignancy in lymph node when compared to biopsy results of the lymph node that was examined.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026