Saini S, Sharma R, Baron R L, Turner D A, Ros P R, Hahn P F, Small W C, Delange E E, Stillman A E, Edelman R R, Runge V M, Outwater E K
Departments of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, USA.
Clin Radiol. 2000 Sep;55(9):690-5. doi: 10.1053/crad.2000.0504.
A dose ranging multicentre phase-II clinical trial was conducted to evaluate the efficacy of ultrasmall superparamagnetic iron oxide (USPIO) ferumoxtran-10 for magnetic resonance (MR) imaging of focal hepatic lesions.
Ninety-nine patients with focal liver lesions received USPIO at a dose of 0.8 (n = 35), 1.1 (n = 32), or 1.7 (n = 32) mg Fe/kg. Liver MR imaging was performed before and after USPIO with T1-weighted and T2-weighted pulse sequences. Images were analysed by two independent readers for additional information (lesion detection, exclusion, characterization and patient management). Signal intensity (SI) based quantitative measurements were also taken.
Post-contrast medium MR imaging showed additional information in 71/97 patients (73%) for reader one and 83/96 patients (86%) for reader two. The results with all three doses were statistically significant (P < 0.05). Signal intensity analysis revealed that all three doses increased liver SI on T1-weighted images and decreased liver SI on T2-weighted images. On T2-weighted images metastases increased in contrast relative to normal hepatic parenchyma whereas haemangiomas decreased in contrast. On T2-weighted images there was statistically improved efficacy at the intermediate dose, which did not improve at the highest dose.
Ultrasmall superparamagnetic iron oxide was an effective contrast agent for liver MR imaging at all doses and a dose of 1.1 mg Fe/kg was recommended for future clinical trials.
开展一项多中心剂量范围Ⅱ期临床试验，以评估超小超顺磁性氧化铁（USPIO） ferumoxtran-10用于局灶性肝病变磁共振（MR）成像的疗效。
99例局灶性肝病变患者接受了剂量为0.8（n = 35）、1.1（n = 32）或1.7（n = 32）mg铁/千克的USPIO。在注射USPIO前后，采用T1加权和T2加权脉冲序列进行肝脏MR成像。由两名独立阅片者分析图像以获取更多信息（病变检测、排除、特征描述及患者管理）。还进行了基于信号强度（SI）的定量测量。
对比剂增强后MR成像显示，阅片者一发现71/97例患者（73%）有更多信息，阅片者二发现83/96例患者（86%）有更多信息。所有三种剂量的结果均具有统计学意义（P < 0.05）。信号强度分析显示，所有三种剂量均使T1加权图像上的肝脏SI增加，T2加权图像上的肝脏SI降低。在T2加权图像上，转移瘤相对于正常肝实质的对比度增加，而血管瘤的对比度降低。在T2加权图像上，中等剂量时疗效有统计学改善，最高剂量时未改善。
超小超顺磁性氧化铁在所有剂量下都是肝脏MR成像的有效对比剂，推荐1.1 mg铁/千克的剂量用于未来的临床试验。
