title: Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules.
abstract: BACKGROUND
  Indeterminate non-calcified lung nodules are frequent when low-dose spiral computed tomography (LD-CT) is used for lung cancer screening. We assessed the diagnostic utility of a non-invasive work-up protocol for nodules detected at baseline in volunteers enrolled in our single-centre screening trial, and followed for at least 1 year.
  
  
  METHODS
  5201 high-risk volunteers, recruited over 1 year from October 2004, underwent baseline LD-CT; 4821 (93%) returned for the first repeat LD-CT. Nodules <or=5mm underwent repeat LD-CT at 1 year; nodules 5.1-8mm underwent LD-CT 3 months later; lesions >8mm received combined CT-positron emission tomography (CT-PET). A subset of nodules >8mm was studied by CT with contrast. Protocol failures were delayed diagnosis with disease progression beyond stage I, and negative surgical biopsy.
  
  
  RESULTS
  2754 (53%) volunteers presented one or more non-calcified nodules. Ninety-two lung cancers were diagnosed: 55 at baseline and 37 at annual screening (66% stage I). Among the 37 incident cancers, 17 had a baseline nodule that remained stage I, 7 had a baseline nodule that progressed beyond stage I, and 13 presented a new malignant nodule. Baseline and annual cancers were 79 (1.5%) and 13 (0.2%), respectively. In 15 of 104 (14%) invasive diagnostic procedures, the lesion was benign. Sensitivity, and specificity were 91 and 99.7%, respectively, for the entire protocol; 88 and 93% for CT-PET; and 100 and 59% for CT with contrast.
  
  
  CONCLUSIONS
  The protocol limits invasive diagnostic procedures while few patients have diagnosis delay, supporting the feasibility of lung cancer screening in high-risk subjects by LD-CT. Nevertheless further optimization of the clinical management of screening-detected nodules is necessary.
authors.affiliation: Department of Thoracic Surgery, European Institute of Oncology, Milan, Italy. giulia.veronesi@ieo.it
authors.forename: Giulia
authors.initials: G
authors.lastname: Veronesi
authors.forename: Massimo
authors.initials: M
authors.lastname: Bellomi
authors.forename: James L
authors.initials: JL
authors.lastname: Mulshine
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pelosi
authors.forename: Paolo
authors.initials: P
authors.lastname: Scanagatta
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paganelli
authors.forename: Patrick
authors.initials: P
authors.lastname: Maisonneuve
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Preda
authors.forename: Francesco
authors.initials: F
authors.lastname: Leo
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bertolotti
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Solli
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Spaggiari
mesh_terms: D000368:Aged; D016009:Chi-Square Distribution; D003287:Contrast Media; D018450:Disease Progression; D005260:Female; D019788:Fluorodeoxyglucose F18; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography / Q000379:methods; D011446:Prospective Studies; D011829:Radiation Dosage; D011857:Radiographic Image Interpretation, Computer-Assisted; D019275:Radiopharmaceuticals; D012680:Sensitivity and Specificity; D018709:Statistics, Nonparametric; D014057:Tomography, X-Ray Computed / Q000379:methods*
chemical_list: D003287:Contrast Media; D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18