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Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer
NCT06577883 · University of California, San Diego
In plain English
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Official title
Chest X-ray Tomosynthesis for Detection of Lung Cancer and Lung Disease
About this study
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.
Eligibility criteria
Inclusion Criteria:
* undergoing lung cancer screening
* undergoing evaluation of suspicious pulmonary nodule
* newly diagnosed lung cancer
Exclusion Criteria:
* prior history of lung cancer treatment
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-02
Estimated completion: 2027-06-30
Last updated: 2024-08-29
Interventions
Diagnostic Test: Chest X-ray Tomosynthesis
Primary outcomes
- • Chest X-ray tomosynthesis detection of lung cancer (through 12/31/2026)
Sponsor
University of California, San Diego · other
With: AIxSCAN, Inc.
Contacts & investigators
ContactAlexander Cypro, MD · contact · aidaresearch2023@gmail.com · 858-2462196
InvestigatorAlbert Hsiao, MD PhD · principal_investigator, UC San Diego, Department of Radiology
All locations (1)
University of California San DiegoRecruiting
San Diego, California, United States