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AI-EBUS-Elastography for LN Staging

S

St. Joseph's Healthcare Hamilton

Status

Completed

Conditions

Endobronchial Ultrasound
Artificial Intelligence
Lung Cancer
Elastography
NSCLC

Treatments

Device: EBUS-Elastography

Study type

Interventional

Funder types

Other

Identifiers

NCT04816981
AI-EBUS-Elastography_19032021

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

EBUS-Elastography
Experimental group
Treatment:
Device: EBUS-Elastography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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