Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540196
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The Development Safety and Feasibility of an Artificial Intelligence-Powered Platform NodeAI for Real-Time Prediction of Mediastinal Lymph Node Malignancy During Endobronchial Ultrasound Staging for Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Development Safety and Feasibility of an Artificial Intelligence-Powered Platform NodeAI for Real-Time Prediction of Mediastinal Lymph Node Malignancy During Endobronchial Ultrasound Staging for Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NodeAI
Brief Summary:
Lung cancer is the leading cause of annual cancer deaths globally more than breast prostate and colon cancers combined The staging of chest lymph nodes LNs is a crucial step in the lung cancer diagnostic pathway because it aids in treatment decisions - whether a patient is a candidate for lung resection chemotherapy radiation or multimodal treatments Endobronchial Ultrasound Transbronchial Needle Aspiration EBUS-TBNA is the current standard for chest nodal staging for non-small cell lung cancer NSCLC and guidelines mandate that Systematic Sampling SS of at least 3 chest LN stations be routinely performed for accurate staging Unfortunately EBUS-TBNA yields inaccurate results in 40 of patients leading to misinformed treatment decisions This proportion is much higher in patients with Triple Normal LNs LNs that appear normal on computed tomography CT scans positron emission tomography PET scans and EBUS which have been found to have a 93 chance of being truly benign This is because EBUS-TBNA is based on ultrasound whose success highly depends on the skill of the person performing it operator When the operator makes an error the entire procedure is jeopardized This causes downstream delays in treatment due to repeated testing and ill-informed treatment decisions
Over the past decade the investigator has been conducting a series of research studies and trials the development and validation of the Canada Lymph Node Score CLNS - a surgeon-derived semi-quantitative measure of LN malignancy an Artificial Intelligence AI-based version of the CLNS to predict malignancy and a fully autonomous AI that learned to predict malignancy directly from ultrasound images to introduce AI to the decision-making pathway in NSCLC This resulted in the creation of an AI-powered software to predict malignancy in mediastinal LNs of patients with lung cancer The software is currently housed in cloud storage and its applications are latent - which means that LN images must be uploaded to the software and results are received at a future time In its current form the software is not ready for clinical application due to this latency In this project the investigator aims to build a point-of-care device which will house the software NodeAI and deliver real-time results to the surgeon and this device will be tested in a clinical trial
Over the past decade the investigator has been conducting a series of research studies and trials the development and validation of the Canada Lymph Node Score CLNS - a surgeon-derived semi-quantitative measure of LN malignancy an Artificial Intelligence AI-based version of the CLNS to predict malignancy and a fully autonomous AI that learned to predict malignancy directly from ultrasound images to introduce AI to the decision-making pathway in NSCLC This resulted in the creation of an AI-powered software to predict malignancy in mediastinal LNs of patients with lung cancer The software is currently housed in cloud storage and its applications are latent - which means that LN images must be uploaded to the software and results are received at a future time In its current form the software is not ready for clinical application due to this latency In this project the investigator aims to build a point-of-care device which will house the software NodeAI and deliver real-time results to the surgeon and this device will be tested in a clinical trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None