Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chest X-ray Tomosynthesis.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 30 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Chest X-ray Tomosynthesis for Detection of Lung Cancer and Lung Disease
Overview
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.
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.
Interventions
- Diagnostic test Chest X-ray Tomosynthesis
An imaging device that uses X-rays projected from multiple angles to reconstruct a three-dimensional images of the chest
Primary outcome measures
- Chest X-ray tomosynthesis detection of lung cancer [Time frame: through 12/31/2026]
Secondary outcome measures (1)
- Chest X-ray tomosynthesis detection of suspicious nodules [Time frame: through 12/31/2026]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California San Diego — San Diego
Identifiers
NCT: NCT06577883 · 805210