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使用SH U 555 C进行的胸部心肌灌注和磁共振血管造影:安慰剂对照的I期临床研究结果

Myocardial perfusion and MR angiography of chest with SH U 555 C: results of placebo-controlled clinical phase i study.

作者信息

Reimer Peter, Bremer Christoph, Allkemper Thomas, Engelhardt Matthias, Mahler Marianne, Ebert Wolfgang, Tombach Bernd

机构信息

Department of Radiology, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of University of Freiburg, Moltkestrasse 90, D-76133 Karlsruhe, Germany.

出版信息

Radiology. 2004 May;231(2):474-81. doi: 10.1148/radiol.2312021251. Epub 2004 Mar 24.

DOI:10.1148/radiol.2312021251
PMID:15044749
Abstract

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 micromol 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 micromol 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 micromol Fe/kg to 907% +/- 370 at 40 micromol 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 micromol Fe/kg has capability for depiction at first-pass MR angiography and for cardiac perfusion.

摘要

目的

评估SH U 555 C用于胸部对比剂增强三维磁共振(MR)血管造影及心肌灌注的效果。

材料与方法

对于胸部MR血管造影,将SH U 555 C以四种剂量(每千克体重5、10、20和40微摩尔铁[Fe])静脉注射入每个剂量组的三名健康志愿者体内,每个剂量组再额外向一名志愿者注射安慰剂(生理盐水)(共16名受试者)。使用体部相控阵线圈,在基线、首次通过时以及注射后6、12、18、24、30、36和42分钟进行胸部的系列高空间分辨率屏气三维MR血管造影。向另外四名志愿者注射SH U 555 C(40微摩尔Fe/千克)以评估心脏灌注。在血管、心腔和心肌中测量信号强度(SI),以计算随时间的相对SI变化。应用方差分析进行多重比较以进行统计分析。两名阅片者评估图像质量。对受试者进行24小时的副作用(心血管反应)监测。

结果

SH U 555 C在首次通过和平衡期显示出剂量依赖性的SI增强增加。SH U 555 C在首次通过时胸主动脉显示出剂量依赖性增加(范围为每千克体重5微摩尔Fe时为259%±160[标准差]至每千克体重40微摩尔Fe时为907%±370)。在平衡期,动脉和静脉血管内的血管内SI随时间没有显著下降。图像质量保持稳定,最高剂量组至30分钟时具有诊断性,即使在较小血管中也具有良好至优异的对比度。对于心脏灌注,SH U 555 C在首次通过右心室和左心室时显示出峰值增强,并且在心腔和心肌的平衡期SI保持稳定。由于磁敏感性效应,首次通过时的峰值增强受到限制,右心室比左心室更明显。造影剂耐受性良好,未发生心血管反应。

结论

以每千克体重40微摩尔Fe的最高剂量推注SH U 555 C具有在首次通过MR血管造影和心脏灌注成像中的显示能力。

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