Indeterminate Lung Nodules in Cancer Patients: Pretest Probability of Malignancy and the Role of18F-FDG PET/CT

OBJECTIVE. The purpose of this study was to determine likelihood of malignancy for indeterminate lung nodules identified on CT comparing two standardized models with 18F-FDG PET/CT. MATERIALS AND METHODS. Fifty-nine cancer patients with indeterminate lung nodules (solid tumors; diameter, ≥ 5 mm) on CT had FDG PET/CT for lesion characterization. Mayo Clinic and Veterans Affairs Cooperative Study models of likelihood of malignancy were applied to solitary pulmonary nodules. High probability of malignancy was assigned a priori for multiple nodules. Low (< 5%), intermediate (5-60%), and high (> 60%) pretest malignancy probabilities were analyzed separately. Patients were reclassified with PET/CT. Histopathology or 2-year imaging follow-up established diagnosis. Outcome-based reclassification differences were defined as net reclassification improvement. A null hypothesis of asymptotic test was applied. RESULTS. Thirty-one patients had histology-proven malignancy. PET/CT was true-positive in 24 and true-negative in 25 cases. Negative predictive value was 78% and positive predictive value was 89%. On the basis of the Mayo Clinic model (n = 31), 18 patients had low, 12 had intermediate, and one had high pretest likelihood; on the basis of the Veterans Affairs model (n = 26), 5 patients had low, 20 had intermediate, and one had high pretest likelihood. Because of multiple lung nodules, 28 patients were classified as having high malignancy risk. PET/CT showed 32 negative and 27 positive scans. Net reclassification improvements respectively were 0.95 and 1.6 for Mayo Clinic and Veterans Affairs models (both p < 0.0001). Fourteen of 31 (45.2%) and 12 of 26 (46.2%) patients with low and intermediate pretest likelihood, respectively, had positive findings on PET/CT for the Mayo Clinic and Veterans Affairs models, respectively. Of 15 patients with high pretest likelihood and negative findings on PET/CT, 13 (86.7%) did not have lung malignancy. CONCLUSION. PET/CT improves stratification of cancer patients with indeterminate pulmonary nodules. A substantial number of patients considered at low and intermediate pretest likelihood of malignancy with histology-proven lung malignancy showed abnormal PET/ CT findings.