Lung Cancer Early Diagnosis With Digital Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Lung cancer is the leading cause of cancer-related death around the world, it represents 13%
      of all new cancer diagnoses. The lung cancer incidence is gradually increasing, especially
      among women and young people, but the fraction of cured patient remains low. In 80% of cases
      lung cancer, in early phase, is treatable only with surgery without chemotherapy or adjuvant
      radiotherapy and the survival perspective at five years exceeds 70%. Several scientific
      guidelines recommends chest CT (computed tomography) in lung cancer screening. Digital
      tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of coronal
      images from a set of projection acquired over a small angle of X-ray tube movement. Several
      studies demonstrates that DTS is a reasonable alternative to the CT and allows a better
      evaluation of suspects nodules compared to conventional chest RX.
    

Detailed description: 
      Lung cancer is the leading cause of cancer-related death around the world. In 2008 there were
      nearly 1.6 million new cases worldwide, accounting for the 12.7% of all new cancer diagnoses.
      Despite decreasing trends in smoking and resulting decrease in lung cancer mortality, the
      population at risk for lung cancer continues to be large. In the past years several programs
      have been developed to screen for lung cancer using low-dose chest computed radiography (CT).
      However, only recently different studies demonstrated a clear reduction in mortality. In
      particular, NLST low dose CT screening trial demonstrated a 6.7% reduction in the death rate
      compared to chest X-ray with a positive screening test rate for lung cancer detection of
      24.2%, compared to 6.9% for conventional X-ray. Digital tomosynthesis (DTS) is a limited
      angle tomography that allows reconstruction of multiple image planes from a set of projection
      data acquired over a relatively small angle of X-ray tube movement. Although it does not have
      the spatial depth resolution of computed tomography, it provides high-resolution images in
      the sagittal planes at a lower dose and cost than CT. Several studies have shown that DTS
      offers advantages over conventional chest X-ray and comparable of those of CT. The Studio
      OSservazionale (SOS) was a clinical trial conducted within Santa Croce e Carle Hospital
      analysing smokers and former smokers aged 45-80 with no cancer diagnosis. All the subjects in
      whom a suspicious nodule was detected by DTS underwent diagnostic CT. The SOS study
      demonstrated that baseline DTS detected pulmonary abnormalities in 14.5% and lung cancer in
      1.0% of the subjects, comparable to results that are obtained in CT screening programs. A
      second DTS, within the same study, executed one year later reported pulmonary abnormalities
      in 0.7% and lung cancer in 0.3% of the subjects.
    

Intervention name(s): diagnosis with tomosynthesis
Intervention type(s): Diagnostic Test
Intervention description(s): Re-evaluation of lung nodule detection rate at 5 years in patients with early diagnosis of lung cancer
Intervention model: Single Group Assignment
Intervention model description: Monocenter prospective no-profit single group interventional study.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: lung; cancer; early diagnosis; DTS