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Randomized Controlled Trial with Low-Dose Spiral CT for Lung Cancer Screening: Feasibility Study and Preliminary Results¹

¹ From the Department of Radiology (K.G., D.A.L.) and Division of Pulmonary Medicine and Critical Care (R.L.K., Y.E.M.), University of Colorado, Denver Veterans Affairs Medical Center; Department of Biostatistics and Epidemiology, School of Medicine, University of Colorado Health Sciences Center, Denver (T.B.); and Department of Oncology, University of Colorado Comprehensive Cancer Center, Denver (K.K., A.L.K.). From the 2001 RSNA scientific assembly. Received November 20, 2001; revision requested January 11, 2002; final revision received April 22; accepted April 25. Supported in part by a grant from the University of Colorado Lung Cancer SPORE (Specialized Program of Research Excellence). Address correspondence to K.G., University of Colorado Hospital, Anchutz Outpatient Pavilion (AOP), Department of Radiology, 1635 N Ursula St, Campus Box F726, Aurora, CO 80010 (e-mail: kavita.garg@uchsc.edu).

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.

© RSNA, 2002

Index terms: Cancer screening, 60.30 • Lung neoplasms, CT, 60.12115 • Lung neoplasms, diagnosis, 60.12115

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