Thrombus Imaging With Fibrin-Specific Gadolinium-Based MR Contrast Agent EP-2104R Results of a Phase II Clinical Study of Feasibility
Thrombus Imaging With Fibrin-Specific Gadolinium-Based MR Contrast Agent EP-2104R Results of a Phase II Clinical Study of Feasibility
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DOI：
10.1097/rli.0b013e3181b092a7
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发表时间：
2009-11-01
影响因子：
6.7
通讯作者：
Parsons, Edward C., Jr.
中科院分区：
文献类型：
--
作者：
Vymazal, Josef;Spuentrup, Elmar;Parsons, Edward C., Jr.
目的：目的：探讨纤维蛋白特异性钆对比剂EP-2104 R用于血栓诊断的可行性。方法：选择静脉系统血栓14例，心脏血栓38例，动脉血栓38例。在4 μ mol/kg EP-2104 R静脉推注之前和之后的不同时间对患者进行成像：< 1小时（N = 16）、2至6小时（N = 36）和/或20至36小时（N = 33）。由每个研究中心的研究者和与研究中心无关的一名阅片人对图像进行评估，以确定血栓是否可见、不可见或用EP-2104 R进一步增强。一个子集的数据进行了定量分析，通过测量相对于背景tissue.Results的信号强度：总的来说，29血栓造影剂前可见，3 14在静脉系统，26 38在动脉和心脏。注射EP-2104 R后血栓信号普遍增强，另外7个可见。造影后，14例血栓中4例可见静脉系统血栓，38例动脉和心脏血栓中32例可见。由于血液背景较低，与1小时内相比，EP-2104 R后2至6小时成像时血栓更加明显。数量，职位：注射后2至6小时的前信号强度比为1.90（标准偏差= 1.08，N = 20，P < 0.001）; 20至36小时时间点的前信号强度比为2.04（标准偏差= 1.29，N = 19，P < 0.0025）。有没有严重的不良事件被认为与study drug.Conclusion：EP-2104 R增强磁共振成像检测血栓不容易在造影剂前筛选可见，并给出了额外的增强血栓是在造影剂前成像可见。
Purpose: To determine the feasibility of detecting thrombi using a fibrin-specific gadolinium-based magnetic resonance imaging contrast agent, EP-2104R.Methods: Subjects with confirmed thrombus in the venous system (n = 14), or in the heart, or arterial system (n = 38) were enrolled. Patients were imaged before and at various times following a 4 mu mol/kg intravenous bolus injection of EP-2104R: < 1 hour (N = 16), 2 to 6 hours (N = 36), and/or 20 to 36 hours (N = 33). Images were assessed by investigators at each site and by a single reader not affiliated with the sites to determine whether thrombi were visible, not visible, or further enhanced with EP-2104R. A subset of data was analyzed quantitatively by measuring a signal intensity relative to background tissue.Results: Overall, 29 thrombi were visible before contrast administration, 3 of 14 in the venous system, and 26 of 38 in the arteries and heart. Thrombi generally enhanced in signal after EP-2104R injection, and an additional 7 were visualized. After contrast, 4 of 14 thrombi were visible in the venous system, and 32 of 38 in the arteries and heart. Thrombi were more conspicuous when imaged at 2 to 6 hours post EP-2104R compared with within I hour, because of lower blood background. Quantitatively, the post: pre signal intensity ratio was 1.90 at 2 to 6 hours post injection (standard deviation = 1.08, N = 20, P < 0.001); and 2.04 (standard deviation = 1.29, N = 19, P < 0.0025) for the 20 to 36 hours time point. There were no serious adverse events considered related to study drug.Conclusion: EP-2104R enhanced magnetic resonance imaging detects thrombi not readily visible in precontrast screening and gives additional enhancement of thrombi that are visible in precontrast imaging.