Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool
Performance Estimation of Triaging Artificial Intelligence Based Computer-Aided Detection Algorithm in Routine Chest Radiography
1 other identifier
observational
44,900
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 25, 2027
July 14, 2026
July 1, 2026
1.8 years
September 12, 2024
July 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
number of patients with actionable lung nodule as measured by CT scan
up to one year
total number of patients having chest x-ray
up to one year
number of patients with high risk lung nodule as measured by CT scan
up to one year
total number of patients referred for a CT scan
up to one year
number of lung nodule positive images
up to one year
number of lung nodule negative images
up to one year
Study Arms (2)
Image going through AI tool
these are the images going through the AI tool
image not going through AI tool
these are the images not going through the AI tool
Interventions
All x-ray images have already been obtained and will then be run through CAD software for secondary nodule detection
Eligibility Criteria
Chest x-rays collected on patients aged 18-89
You may qualify if:
- Chest X-ray images of patients aged 18 - 89 years.
- Modality: CR/DR/DX.
- PA/view
- Lung nodules measuring 6 mm -30 mm (for chest X-ray images where presence of nodules is required).
You may not qualify if:
- Incomplete view of the chest.
- Lateral view
- Known lung cancer at the time of Chest x-ray images.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals
Cleveland, Ohio, 44106, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Gupta, MD
University Hospitals Cleveland Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Radiology, School of Medicine Member, Cancer Imaging Program, Case Comprehensive Cancer Center, Cardiothoracic Division Chief department of Radiology
Study Record Dates
First Submitted
September 12, 2024
First Posted
September 19, 2024
Study Start
June 24, 2025
Primary Completion (Estimated)
April 25, 2027
Study Completion (Estimated)
April 25, 2027
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share