To determine the utility of contrast material-enhanced ultrasonography (US) in the characterization of indeterminate renal masses. This retrospective performance study was approved by the institutional review board and was HIPAA compliant, with waiver of informed consent. Patients included 721 individuals referred for contrast-enhanced US with 1018 indeterminate renal masses from 1999 to 2010, identified initially with an imaging study. Three hundred twenty patients (44.4%) were female, and 401 (55.6%) were male. Patient ages ranged from 17 to 95 years (mean ± standard deviation, 70 years ± 15). Lesion size varied from 2 to 161 mm (mean, 26.6 mm ± 19.5). Contrast-enhanced US enhancement patterns were used to characterize masses as benign or malignant. For lesions with a definitive diagnosis, 306 of 1018 (30.0%) were correlated with contrast-enhanced US findings: 167 (54.6%) were benign, and 139 (45.4%) were malignant. For lesions without a pathologic diagnosis, 712 (70.0%) were followed for as long as 10 years. Diagnostic accuracy measures were calculated by using pathologic diagnosis as the reference standard, as well as lesion stability at 3 and 5 years. Contrast-enhanced US had a sensitivity of 100% (126 of 126; 95% confidence interval [CI]: 97.1%, 100%), specificity of 95.0% (132 of 139; 95% CI: 89.9%, 98.0%), positive predictive value (PPV) of 94.7% (126 of 133), and negative predictive value (NPV) of 100% (132 of 132). The five false-positive masses included three oncocytomas and two Bosniak category 3 cystic lesions. Of the 290 lesions that had follow-up of at least 36 months, none of the lesions demonstrated changes that necessitated lesion reclassification. If these lesions were included, assuming lesions classified as malignant were malignant, then of the 596 lesions, sensitivity was 100% (161 of 161), specificity was 96.6% (420 of 435), PPV was 91.5% (161 of 176), and NPV was 100% (420 of 420). Contrast-enhanced US evaluation is a highly sensitive and specific method for characterization of indeterminate renal masses. Online supplemental material is available for this article.
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