A multicenter, prospective, open label, randomized, controlled phase IIIb study of SH U 508 A [Levovist®) for Doppler signal enhancement in the portal vascular system

Purpose: Assessment of the accuracy of SH U 508 A (Levovist(R)) enhanced Doppler sonography in the evaluation of blood flow abnormalities in the portal vascular system. Method: In an open label, controlled, prospective multicenter study, patients referred for Doppler sonography of the portal vascular system were randomized to receive SH U 508 A if indicated or to an observation group (ratio of 4:1). Patients who had diagnostically insufficient Doppler signals received SH U 508 A (2,5 g [200, 300 or 400 mg/ml]), followed by confirmatory dynamic CT. Corresponding patients in the observation group received alternative imaging procedure(s). Results: Of 588 patients 265 patients received SH U 508 A. In 253 (95.5 %) of these patients a diagnosis was possible following administration of SH U 508 A (Levovist(R)). Diagnostic confidence improved from 35.3% to 89.7%. If compared with dynamic CT, SH U 508 A enhanced Doppler had a sensitivity of 80.5% and a specificity of 89.7%;. Whereas diagnosis was not possible with SH U 508 A enhanced Doppler in only 12 patients, a diagnosis was not possible in 29 patients with dynamic CT. SH U 508 A enhanced Doppler in particular improved visualization of the portal vein (15.6%), TIPS (15.8%), superior mesenteric vein (16.1%), collateral circulation (20.7%) and inferior mesenteric vein (25%). SH U 508 A was very well tolerated; only eight patients experienced minor adverse events possibly related to SH U 508 A administration. Conclusion: SH U 508 A enhanced Doppler improved the diagnostic confidence and visualization of the portal vascular system compared to base line scans with insufficient Doppler signal and proved reliable compared to dynamic CT.