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

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Completed
CT.gov ID
NCT03849040
Collaborator
(none)
52
1
7.4
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endobronchial Ultrasound

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
52 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Apr 8, 2019
Actual Primary Completion Date :
Sep 23, 2019
Actual Study Completion Date :
Nov 20, 2019

Outcome Measures

Primary Outcome Measures

  1. Development of computer algorithm to identify lymph node ultrasonographic features [From 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

  2. Validation of computer algorithm to identify lymph node ultrasonographic features [From 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 Outcome Measures

  1. Accuracy and reliability of the segmentation performed by NeuralSeg [From 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.

  2. NeuralSeg prediction of lymph node malignancy [From 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • must be diagnosed with confirmed or suspected lung cancer and be undergoing EBUS diagnosis/staging
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N 4A6

Sponsors and Collaborators

  • St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Wael C Hanna, St. Josephs Healthcare Hamilton

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wael Hanna, Dr. Waël Hanna, MDCM, MBA, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT03849040
Other Study ID Numbers:
  • StJoes EBUS AI (5636)
First Posted:
Feb 21, 2019
Last Update Posted:
Mar 11, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wael Hanna, Dr. Waël Hanna, MDCM, MBA, FRCSC, St. Joseph's Healthcare Hamilton
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2020