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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).

View larger version (37K): [in a new window]   Figure 1. Graph shows dose-dependent enhancement during first pass and equilibrium phase at SH U 555 C-enhanced MR angiography within thoracic aorta. Relative SI enhancement within aorta during first pass (0.1 minute = 12 seconds) and equilibrium phase is displayed as mean value to avoid overlapping error bars (Table 1). SH U 555 C shows statistically significant dose-dependent first-pass effect. Values for each dose do not significantly decrease during observation period. Only the difference between the dose of 10 µmol Fe/kg () and that of 20 µmol Fe/kg (x) was not significant during equilibrium phase. = 5 µmol Fe/kg, = 40 µmol Fe/kg.

View larger version (128K): [in a new window]   Figure 2. SH U 555 C-enhanced coronal three-dimensional MR angiographic images (4.6/1.8; flip angle, 30o) of thoracic aorta. Doses of 20 µmol Fe/kg (top row) and 40 µmol Fe/kg (bottom row) are compared during first pass (left column) and equilibrium phase at 12 (middle column) and 42 (right column) minutes after SH U 555 C injection. SH U 555 C shows dose-dependent first-pass effect. During equilibrium phase, enhancement at 40 µmol Fe/kg is higher.

View larger version (159K): [in a new window]   Figure 3. SH U 555 C-enhanced coronal three-dimensional MR angiographic image (4.6/1.8; flip angle, 30o) within pulmonary arteries at first pass. Doses of 5, 10, 20, and 40 µmol Fe/kg are compared. Visibility of pulmonary arteries improves with increasing dose and is best for highest dose of 40 µmol Fe/kg.

View larger version (33K): [in a new window]   Figure 4a. Images show cardiac enhancement with SH U 555 C and perfusion. (a) Graph shows that short-axis cardiac perfusion images with 40 µmol Fe/kg dose have an early peak at 7 seconds within the right ventricle, followed by an SI decrease at 12 seconds with a second pass and subsequent stable equilibrium phase after 30 seconds. Left ventricle demonstrates first peak at 12 seconds, followed by SI decrease at 19 seconds, second peak at 26 seconds, and subsequent equilibrium phase with continuous (not significant) SI increase during time. Enhancement (ENH) within myocardium of left ventricle shows initial increase during first pass, with maximum at 23 seconds followed by small decrease and subsequent stable equilibrium phase after 30 seconds. Enhancement within left ventricle = A – ENH LV, within right ventricle = B – ENH RV, and within left ventricular myocardium = C – ENH LV Myocard. (b) Short-axis T1-weighted turbo fast low-angle shot MR images (416/1.2/200; delay, 50 msec; flip angle, 8o; time resolution, one image per second) obtained at different times (top left to bottom right) after SH U 555 C (40 µmol Fe/kg) injection show cardiac perfusion. Images show time course with inflow into right and left ventricles and myocardial enhancement. Enhancement within right ventricle with subsequent passage through pulmonary circulation is followed by enhancement within left ventricle and myocardium. pre = precontrast image. (c) Color-coded mean transit time map with homogeneous signal throughout myocardium. Cardiac perfusion data sets obtained at 40 µmol Fe/kg were postprocessed, and parameter maps were generated to test for feasibility of calculation of maps. Images may be used to visualize regional perfusion changes within myocardium.

View larger version (167K): [in a new window]   Figure 4b. Images show cardiac enhancement with SH U 555 C and perfusion. (a) Graph shows that short-axis cardiac perfusion images with 40 µmol Fe/kg dose have an early peak at 7 seconds within the right ventricle, followed by an SI decrease at 12 seconds with a second pass and subsequent stable equilibrium phase after 30 seconds. Left ventricle demonstrates first peak at 12 seconds, followed by SI decrease at 19 seconds, second peak at 26 seconds, and subsequent equilibrium phase with continuous (not significant) SI increase during time. Enhancement (ENH) within myocardium of left ventricle shows initial increase during first pass, with maximum at 23 seconds followed by small decrease and subsequent stable equilibrium phase after 30 seconds. Enhancement within left ventricle = A – ENH LV, within right ventricle = B – ENH RV, and within left ventricular myocardium = C – ENH LV Myocard. (b) Short-axis T1-weighted turbo fast low-angle shot MR images (416/1.2/200; delay, 50 msec; flip angle, 8o; time resolution, one image per second) obtained at different times (top left to bottom right) after SH U 555 C (40 µmol Fe/kg) injection show cardiac perfusion. Images show time course with inflow into right and left ventricles and myocardial enhancement. Enhancement within right ventricle with subsequent passage through pulmonary circulation is followed by enhancement within left ventricle and myocardium. pre = precontrast image. (c) Color-coded mean transit time map with homogeneous signal throughout myocardium. Cardiac perfusion data sets obtained at 40 µmol Fe/kg were postprocessed, and parameter maps were generated to test for feasibility of calculation of maps. Images may be used to visualize regional perfusion changes within myocardium.

View larger version (30K): [in a new window]   Figure 4c. Images show cardiac enhancement with SH U 555 C and perfusion. (a) Graph shows that short-axis cardiac perfusion images with 40 µmol Fe/kg dose have an early peak at 7 seconds within the right ventricle, followed by an SI decrease at 12 seconds with a second pass and subsequent stable equilibrium phase after 30 seconds. Left ventricle demonstrates first peak at 12 seconds, followed by SI decrease at 19 seconds, second peak at 26 seconds, and subsequent equilibrium phase with continuous (not significant) SI increase during time. Enhancement (ENH) within myocardium of left ventricle shows initial increase during first pass, with maximum at 23 seconds followed by small decrease and subsequent stable equilibrium phase after 30 seconds. Enhancement within left ventricle = A – ENH LV, within right ventricle = B – ENH RV, and within left ventricular myocardium = C – ENH LV Myocard. (b) Short-axis T1-weighted turbo fast low-angle shot MR images (416/1.2/200; delay, 50 msec; flip angle, 8o; time resolution, one image per second) obtained at different times (top left to bottom right) after SH U 555 C (40 µmol Fe/kg) injection show cardiac perfusion. Images show time course with inflow into right and left ventricles and myocardial enhancement. Enhancement within right ventricle with subsequent passage through pulmonary circulation is followed by enhancement within left ventricle and myocardium. pre = precontrast image. (c) Color-coded mean transit time map with homogeneous signal throughout myocardium. Cardiac perfusion data sets obtained at 40 µmol Fe/kg were postprocessed, and parameter maps were generated to test for feasibility of calculation of maps. Images may be used to visualize regional perfusion changes within myocardium.