Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597968
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Performance Estimation of Triaging Artificial Intelligence Based Computer-Aided Detection Algorithm in Routine Chest Radiography
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
chest x-rays will be analyzed by AI software for a secondary read of lung nodules Chest x-rays will either be sent to the AI tool to be read or to radiologists to read If the image is sent to the AI tool the AI software will generate a report on if it detects a lung nodule or not The image will then be sent to a radiologist to determine if there is agreement or disagreement with the AI tool
Detailed Description:
The study is a prospective study for measuring the performance of an AI software in detecting lung nodules from chest X-rays Data collected during the study will be analyzed for study purposes after end date of data collection
There will be two study arms the control arm and the interventional arm
Control Arm
There will be no interruption to the existing standard of care pathway
Interventional Arm
Use of AI will occur in parallel to the standard of care pathway
Consistent with the control Arm the radiologists or clinicians interpreting the chest x-ray images will proceed as usual based on the existing standard operating procedures of the study site In addition the AI software will function as a second reader meaning images will be processed by the AI software which will generate a report
In the event that the radiologist and the AI tool do not agree cases will be reviewed by qualified study team members twice per week
There will be two study arms the control arm and the interventional arm
Control Arm
There will be no interruption to the existing standard of care pathway
Interventional Arm
Use of AI will occur in parallel to the standard of care pathway
Consistent with the control Arm the radiologists or clinicians interpreting the chest x-ray images will proceed as usual based on the existing standard operating procedures of the study site In addition the AI software will function as a second reader meaning images will be processed by the AI software which will generate a report
In the event that the radiologist and the AI tool do not agree cases will be reviewed by qualified study team members twice per week
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