• Randomized Controlled Trial with Low-Dose Spiral CT for Lung Cancer Screening: Feasibility Study and Preliminary Results

    Radiology 2002; 225:506-510.

    Garg K, Keith RL, Byers T, Kelly K, Kerzner AL, Lynch DA, Miller YE.

    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 \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.