McGregor Robert, Vymazal Josef, Martinez-Lopez Manuel, Neuwirth Jiri, Salgado Perla, Beregi Jean-Paul, Peduto Anthony, de la Pena-Almaguer Erasmo, Slater Greg J, Shamsi Kohkan, Parsons Edward C
St. Boniface General Hospital, Winnipeg, Manitoba, Canada.
Eur J Radiol. 2008 Feb;65(2):316-25. doi: 10.1016/j.ejrad.2007.03.018. Epub 2007 May 17.
To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA).
Gadofosveset (0.03 mmol/kg) was administered to adult patients with known or suspected renal arterial disease in a multi-center phase 3 single dose study. The drug binds reversibly to albumin, prolonging the blood residence time, and allowing collection of images in the first-pass and steady-state phases. The combination of these images was compared to non-contrast MRA, using catheter X-ray angiography (XRA) as the standard of reference (SOR). All MRA images were collected at 1.5 T in one imaging session for direct comparison, and XRA within 30 days. Sensitivity, specificity, and accuracy for diagnosing significant disease (stenosis > or =50%) were calculated for MRA using three independent blinded readers. Patient safety was monitored for 72-96 h.
A total of 145 patients at 18 centers were enrolled and received gadofosveset; the 127 with complete efficacy data entered the primary efficacy analysis. Gadofosveset-enhanced MRA led to significant improvement (p<0.01) in sensitivity (+25%, +26%, +42%), specificity (+23%, +25%, +29%), and accuracy (+23%, +28%, +29%) over non-enhanced MRA for the three readers. The rate of uninterpretable examinations decreased from 30% to less than 2%. There were no serious adverse events, and the most common adverse events were nausea, pruritus, and headache (8% each). No significant trends in clinical chemistry parameters, nor significant changes in serum creatinine, were found following administration of gadofosveset.
In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.
前瞻性地确定血池造影剂钆布醇三钠在肾动脉磁共振血管造影（MRA）中的安全性和有效性。
在一项多中心3期单剂量研究中，对已知或疑似肾动脉疾病的成年患者给予钆布醇（0.03 mmol/kg）。该药物与白蛋白可逆性结合，延长血液停留时间，并允许在首过和稳态期采集图像。将这些图像的组合与非增强MRA进行比较，以导管X线血管造影（XRA）作为参考标准（SOR）。所有MRA图像均在1.5 T下于一次成像检查中采集以进行直接比较，XRA在30天内进行。由三名独立的盲法阅片者计算MRA诊断显著疾病（狭窄≥50%）的敏感性、特异性和准确性。对患者安全性进行72 - 96小时的监测。
18个中心共有145例患者入组并接受了钆布醇；127例具有完整疗效数据的患者进入主要疗效分析。与非增强MRA相比，钆布醇增强MRA使三名阅片者的敏感性（分别提高25%、26%、42%）、特异性（分别提高23%、25%、29%）和准确性（分别提高23%、28%、29%）有显著改善（p<0.01）。无法解读的检查率从3%降至2%以下。未发生严重不良事件，最常见的不良事件为恶心、瘙痒和头痛（各8%）。给予钆布醇后，临床化学参数无显著趋势，血清肌酐也无显著变化。
在已知或疑似肾动脉疾病的患者中，多期钆布醇增强MRA与非增强MRA相比，显著提高了敏感性、特异性和准确性。钆布醇在该患者群体中安全且耐受性良好。
