Multicenter phase-II trial of safety and efficacy of NC100150 for steady-state contrast-enhanced peripheral magnetic resonance angiography.

Abstract

The aim of this study was to test the safety and efficacy of NC100150 injection for steady-state contrast-enhanced peripheral MR angiography in a multicentre phase-II trial. Thirty-three patients underwent steady-state NC100150 enhanced MR angiography (5 mg Fe/kg body weight) of the aortoiliac and femoropopliteal arteries. Safety assessment consisted of pre- and post-injection (2, 24 and 72 h) monitoring of vital signs, physical examination as well as laboratory and electrocardiographic parameters. To determine sensitivity and specificity for detection of haemodynamically significant stenoses (HSS; >50% reduction of luminal diameter) MR angiograms were compared with intra-arterial digital subtraction angiography (IA DSA), which was considered the standard of reference. In 33 patients a mean of 12.8 ml NC100150 was injected. Eleven patients reported 13 mild and 2 moderate adverse events. Five mild and one moderate adverse event were considered due to NC100150 injection. There were no significant changes in vital signs, laboratory or electrocardiographic parameters. Sensitivity and specificity (in percent) for detection of HSS were 87 and 64, 56 and 76, and 75 and 84, for iliac, femoral and popliteal arteries, respectively. NC100150 high-resolution steady-state MR angiography can be performed safely and is feasible for the detection of peripheral arterial HSS, but is as yet not a clinically useful alternative to conventional gadolinium-enhanced MR angiography.