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Myocardial Perfusion and MR Angiography of Chest with SH U 555 C: Results of Placebo-controlled Clinical Phase I Study¹

¹ From the Department of Radiology, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of University of Freiburg, Moltkestrasse 90, D-76133 Karlsruhe, Germany (P.R., M.E.); Department of Clinical Radiology, University of Muenster, Germany (C.B., T.A., B.T.); and Schering, Berlin, Germany (M.M., W.E.). Received October 8, 2002; revision requested December 12; final revision received October 5, 2003; accepted October 28. Supported in part by Schering, Berlin, Germany. Address correspondence to P.R. (e-mail: p.reimer@web.de).

PURPOSE: To evaluate SH U 555 C for contrast material–enhanced three-dimensional magnetic resonance (MR) angiography of the chest and myocardial perfusion.

MATERIALS AND METHODS: For chest MR angiography, SH U 555 C was intravenously injected at four doses (5, 10, 20, and 40 µmol iron [Fe] per kilogram of body weight) into three healthy volunteers per dose group, and placebo (saline) was injected into one additional volunteer per dose group (16 subjects). With a body phased-array coil, serial high-spatial-resolution breath-hold three-dimensional MR angiography of the chest was performed at baseline, first pass, and 6, 12, 18, 24, 30, 36, and 42 minutes after injection. SH U 555 C (40 µmol Fe/kg) was injected into four additional volunteers to evaluate cardiac perfusion. Signal intensity (SI) was measured in vessels, cardiac chambers, and myocardium to calculate relative SI changes during time. Analysis of variance for multiple comparisons was applied for statistical analysis. Two readers assessed image quality. Subjects were monitored for side effects (cardiovascular reactions) for 24 hours.

RESULTS: SH U 555 C showed a dose-dependent increase in SI enhancement during first pass and equilibrium phase. SH U 555 C showed dose-dependent increase (range, 259% ± 160 [SD] at 5 µmol Fe/kg to 907% ± 370 at 40 µmol Fe/kg) for thoracic aorta during first pass. Intravascular SI did not significantly decrease with time during equilibrium phase within arterial and venous vessels. Image quality remained stable and was diagnostic for highest dose group to 30 minutes, with good to excellent contrast even in smaller blood vessels. For cardiac perfusion, SH U 555 C showed peak enhancement during first pass through right and left ventricles, as well as stable SI during equilibrium phase within cardiac chambers and myocardium. Peak enhancement during first pass was limited due to susceptibility effects, which were more pronounced in right ventricle than in left. Contrast agent was well tolerated, and no cardiovascular reactions occurred.

CONCLUSION: SH U 555 C bolus injected at highest dose of 40 µmol Fe/kg has capability for depiction at first-pass MR angiography and for cardiac perfusion.

© RSNA, 2004

Index terms: Iron • Magnetic resonance (MR), contrast enhancement, 56.12142, 56.12143 • Magnetic resonance (MR), perfusion study, 511.12144, 523.12144, 524.12144, 56.12144 • Magnetic resonance (MR), vascular studies, 51.12142, 56.12142 • Thorax, MR, 51.12142, 56.12142

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