Randomized controlled trial with low-dose spiral CT for lung cancer screening: feasibility study and preliminary results

Radiology. 2002 Nov;225(2):506-10. doi: 10.1148/radiol.2252011851.


Purpose: To assess the feasibility of conducting a randomized controlled trial for lung cancer screening.

Materials and 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.

Conclusion: Findings of this study indicate that a randomized controlled trial of CT to screen for lung cancer is feasible.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Carcinoma, Bronchogenic / diagnostic imaging*
  • Colorado
  • Feasibility Studies
  • Hospitals, Veterans
  • Humans
  • Lung Neoplasms / diagnostic imaging*
  • Mass Screening*
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive / diagnostic imaging
  • Radiation Dosage
  • Risk
  • Sensitivity and Specificity
  • Smoking / adverse effects
  • Solitary Pulmonary Nodule / diagnostic imaging
  • Sputum / cytology
  • Tomography, Spiral Computed*
  • Veterans*