| Abstract: | In a phase IIIb clinical trial of the ultrasound contrast agent Levovist® (Schering AG, Berlin, Germany), the role of Levovist® in the management of patients with clinically suspected hepatocellular carcinoma (HCC) was evaluated and its efficacy was assessed. The assessment included the duration of diagnostically usable Doppler signal enhancement, and safety and tolerance of intravenous administration. All patients with clinically suspected hepatocellular carcinoma were referred for Doppler sonographic examination over a 5-month period and lesions with absent or suboptimal Doppler signals were included in the trial. A total of 300 mg/mL in concentration (8.5 mL) of Levovist® was administered through a peripheral vein while Doppler signal intensity in the lesion, based on a visual score, was recorded. Blood pressure and pulse were recorded before and after injection. Thirty-eight patients were examined, of which 29 were included in the trial. The lesions were subsequently proven histologically to be 19 HCC, one cholangiocarcinoma, two regeneration nodules and one colonic metastasis. For six patients in whom histological proof was not available, the diagnosis of HCC was suggested based on markedly elevated serum alpha-fetoprotein levels. All but one (96%) of the 25 HCC demonstrated increased Doppler signal after Levovist®. There were no Doppler signals before and after Levovist® injection in three non-HCC lesions (two regeneration nodules and one colonic metastasis). Two patients (6.9%) suffered minor adverse reactions of nausea and vomiting. The results show that Levovist® is safe and is able to improve lesion characterization and increase diagnostic confidence of hepatocellular carcinoma by enhancing tumour vascularization Doppler signal intensity. |
