title: Randomized controlled trial with low-dose spiral CT for lung cancer screening: feasibility study and preliminary results.
abstract: OBJECTIVE
  To assess the feasibility of conducting a randomized controlled trial for lung cancer screening.
  
  
  METHODS
  Subjects are being recruited into a randomized controlled trial to undergo either low-dose spiral computed tomography (CT) or observation. Subjects are from a high-risk group with known chronic obstructive pulmonary disease and sputum atypia and a moderate-risk group randomly selected from the general population of a Veterans Affairs Medical Center. All subjects must be 50-80 years of age with 30 or more pack-years of cigarette smoking and must not have undergone chest CT during the previous 3 years. Baseline screening CT is performed with 50 mA, 120 kVp, 5-mm collimation, and a pitch of 2. CT scan interpretation and management of nodules is based on Society of Thoracic Radiology guidelines. The chi(2) test for categoric data was used for statistical analysis.
  
  
  RESULTS
  To date, 304 eligible subjects have been contacted, and 239 (79%) have agreed to participate in the trial. One hundred nineteen (88%) of the 136 subjects in the high-risk group and 120 (71%) of the 168 subjects in the moderate-risk group agreed to randomization (P <.001). To date, 190 subjects have been randomized. Of the first 92 subjects examined with CT, 22 (40%) of 55 in the high-risk group and eight (22%) of 37 in the moderate-risk group had one to six noncalcified nodules that required follow-up (P =.07). In all but three subjects, nodules were smaller than 5 mm. Two of the three larger nodules were malignancies.
  
  
  CONCLUSIONS
  Findings of this study indicate that a randomized controlled trial of CT to screen for lung cancer is feasible.
authors.affiliation: Department of Radiology, University of Colorado, Denver Veterans Affairs Medical Center, USA. kavita.garg@uchsc.edu
authors.forename: Kavita
authors.initials: K
authors.lastname: Garg
authors.forename: Robert L
authors.initials: RL
authors.lastname: Keith
authors.forename: Tim
authors.initials: T
authors.lastname: Byers
authors.forename: Karen
authors.initials: K
authors.lastname: Kelly
authors.forename: Anne L
authors.initials: AL
authors.lastname: Kerzner
authors.forename: David A
authors.initials: DA
authors.lastname: Lynch
authors.forename: York E
authors.initials: YE
authors.lastname: Miller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002283:Carcinoma, Bronchogenic / Q000000981:diagnostic imaging*; D003120:Colorado; D005240:Feasibility Studies; D006787:Hospitals, Veterans; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging*; D008403:Mass Screening; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000000981:diagnostic imaging; D011829:Radiation Dosage; D012306:Risk; D012680:Sensitivity and Specificity; D012907:Smoking / Q000009:adverse effects; D003074:Solitary Pulmonary Nodule / Q000000981:diagnostic imaging; D013183:Sputum / Q000166:cytology; D036542:Tomography, Spiral Computed; D014728:Veterans