The purpose of this study was to evaluate the clinical usefulness of a galactose-based, IV sonographic contrast agent for assessing tumor vascularity and diagnosing hepatocellular carcinoma. We used color Doppler sonography with the sonographic contrast agent to examine 22 patients with 26 hepatic nodules (18 hepatocellular carcinomas, four hemangiomas, two adenomatous hyperplasias, and two metastatic tumors). In all 26 lesions, intratumoral arterial flow signals were examined before and after IV injection of the sonographic contrast agent at three concentrations (200, 300, and 400 mg/ml), and the findings on color Doppler sonograms of each lesion were correlated with angiographic findings. Conventional color Doppler sonograms showed flow in nine hepatocellular carcinomas (50%) and one hemangioma (25%). When the contrast agent was used, color Doppler sonograms showed intratumoral arterial flow in 11 hepatocellular carcinomas (61%) and one hemangioma (25%) at a concentration of 200 mg/ml, in 14 hepatocellular carcinomas (78%) and 1 hemangioma (25%) at 300 mg/ml, and in 15 hepatocellular carcinomas (83%) and two hemangiomas (50%) at 400 mg/ml. The detectability of intratumoral arterial flow was improved by the contrast agent, especially in hepatocellular carcinomas smaller than 30 mm in diameter. Angiography revealed neovascularization or staining in 15 hepatocellular carcinomas, four hemangiomas, and none of the adenomatous hyperplasias or metastatic tumors. Among 15 angiographically hypervascular hepatocellular carcinomas, the detection rate of intratumoral arterial flow with contrast-enhanced color Doppler sonography was 73% at 200 mg/ml, 93% at 300 mg/ml, and 100% at 400 mg/ml. No intratumoral Doppler signals were depicted with the use of contrast agent in any angiographically undetected tumors. Preliminary findings on contrast-enhanced color Doppler sonograms correlate well with angiographic findings for evaluating tumor vascularity. This noninvasive technique may be useful in diagnosing hypervascular hepatocellular carcinomas.