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) 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). 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.