Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577883
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Chest X-ray Tomosynthesis for Detection of Lung Cancer and Lung Disease
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images The main questions it aims to answer are
What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule
Can artificial intelligence help us detect lung cancer on chest tomosynthesis images
Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer
Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan
What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule
Can artificial intelligence help us detect lung cancer on chest tomosynthesis images
Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer
Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan
Detailed Description:
Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer However adoption remains low Furthermore 95 of nodules detected on low-dose CT especially those smaller than 6 mm do not represent cancer We have partnered to develop a novel chest x-ray tomosynthesis CXRT device with the hypothesis that this device might be an alternative to CT for detection of lung cancer We seek to recruit a cohort of patients to undergo CXRT composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer We will determine the effectiveness of CXRT for detecting lung cancer in this population evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection
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