Goyen Mathias, Edelman Mark, Perreault Pierre, O'Riordan Elaine, Bertoni Hernan, Taylor James, Siragusa Daniel, Sharafuddin Melhem, Mohler Emile R, Breger Robert, Yucel E Kent, Shamsi Kohkan, Weisskoff Robert M
Department of Diagnostic and Interventional Radiology, University Hospital Essen, Hufelandstrasse 55, 45147 Essen, Germany. mathias.goyen.de
Radiology. 2005 Sep;236(3):825-33. doi: 10.1148/radiol.2363040577. Epub 2005 Jul 14.
To evaluate prospectively the safety and effectiveness of aortoiliac magnetic resonance (MR) angiography enhanced with MS-325 (gadofosveset trisodium) at a dose of 0.03 mmol/kg; effectiveness was defined as accuracy relative to the reference standard, conventional angiography.
Study was approved by institutional review boards of participating institutions, and required national approvals were obtained. Study protocol conformed to Good Clinical Practice guidelines, and informed patient consent was obtained. Patients with known or suspected peripheral vascular disease received 0.03 mmol/kg MS-325 for aortoiliac MR angiography. They were also examined with conventional angiography. MS-325-enhanced MR was evaluated for safety and effectiveness. Along with unenhanced two-dimensional time-of-flight MR angiography, it was compared with conventional angiography for presence of vascular stenosis. Student t tests were used to identify significant improvement in diagnostic sensitivity, specificity, and accuracy, as well as quantitative characterization of stenoses by three blinded readers. Correlations between readers of conventional angiograms were calculated and compared with MR results.
In 174 patients, MS-325-enhanced MR angiography showed significant improvement (P < or = .001) in sensitivity, specificity, and accuracy for diagnosis of clinically significant (> or =50%) stenosis, compared with unenhanced MR. For all readers, areas under the receiver operating characteristic curve for both quantitative and qualitative measures of significant disease increased (P < .001) for MS-325-enhanced MR compared with time-of-flight MR. All readers also expressed higher confidence in diagnosis (P < .001) and found fewer images uninterpretable with MS-325 enhancement. All measures of interpretation accuracy approached corresponding measures of correlation between readers of conventional angiograms. Incidence of severe and serious adverse events with MS-325 was low. No patients were withdrawn from study due to adverse events or abnormalities in laboratory results. There were no clinically important trends in findings at hematology, blood chemistry, urinalysis, electrocardiography, or physical examination.
MR angiography with MS-325 provides significant improvement in effectiveness over unenhanced MR (and minimal and transient side effects) at a dose of 0.03 mmol/kg and was safe and effective for MR evaluation of patients with aortoiliac occlusive disease.
前瞻性评估以0.03 mmol/kg剂量的MS-325（钆特酸三钠）增强的腹主动脉-髂动脉磁共振（MR）血管造影的安全性和有效性；有效性定义为相对于参考标准——传统血管造影的准确性。
研究经参与机构的机构审查委员会批准，并获得国家所需的批准。研究方案符合良好临床实践指南，并获得患者知情同意。已知或疑似患有周围血管疾病的患者接受0.03 mmol/kg的MS-325用于腹主动脉-髂动脉MR血管造影。他们还接受了传统血管造影检查。对MS-325增强的MR进行安全性和有效性评估。除了未增强的二维时间飞跃MR血管造影外，将其与传统血管造影在血管狭窄情况方面进行比较。采用学生t检验来确定诊断敏感性、特异性和准确性的显著提高，以及三位盲法阅片者对狭窄的定量特征分析。计算传统血管造影阅片者之间的相关性，并与MR结果进行比较。
在174例患者中，与未增强的MR相比，MS-325增强的MR血管造影在诊断具有临床意义（≥50%）狭窄的敏感性、特异性和准确性方面有显著提高（P≤0.001）。对于所有阅片者，与时间飞跃MR相比，MS-325增强的MR在重大疾病的定量和定性测量方面，受试者操作特征曲线下面积均增加（P<0.001）。所有阅片者对诊断的信心也更高（P<0.001），并且发现MS-325增强后无法解读的图像更少。所有解读准确性的测量结果均接近传统血管造影阅片者之间的相应相关性测量结果。MS-325导致的严重和重大不良事件发生率较低。没有患者因不良事件或实验室结果异常而退出研究。在血液学、血液化学、尿液分析、心电图或体格检查中，检查结果没有临床上重要的趋势。
在0.03 mmol/kg剂量下，MS-325增强的MR血管造影在有效性方面比未增强的MR有显著提高（且副作用轻微且短暂），对于腹主动脉-髂动脉闭塞性疾病患者的MR评估是安全有效的。
