Knopp Michael V, Bourne Michael W, Sardanelli Francesco, Wasser Martin N, Bonomo Lorenzo, Boetes Carla, Müller-Schimpfle Markus, Hall-Craggs Margaret A, Hamm Bernd, Orlacchio Antonio, Bartolozzi Carlo, Kessler Mareike, Fischer Uwe, Schneider Günther, Oudkerk Matthijs, Teh William L, Gehl Hans-Björn, Salerio Isabella, Pirovano Gianpaolo, La Noce Anna, Kirchin Miles A, Spinazzi Alberto
Department of Radiology, German Cancer Research Center, Im Neuenheimer Feld 280, D-69120 Heidelberg, Germany.
AJR Am J Roentgenol. 2003 Sep;181(3):663-76. doi: 10.2214/ajr.181.3.1810663.
The purpose of this study was to evaluate the clinical efficacy and dose response relationship of three doses of gadobenate dimeglumine for MRI of the breast and to compare the results with those obtained after a dose of 0.1 mmol/kg of body weight of gadopentetate dimeglumine. SUBJECTS AND METHODS. Gadobenate dimeglumine at 0.05, 0.1, or 0.2 mmol/kg of body weight or gadopentetate dimeglumine at 0.1 mmol/kg of body weight was administered by IV bolus injection to 189 patients with known or suspected breast cancer. Coronal three-dimensional T1-weighted gradient-echo images were acquired before and at 0, 2, 4, 6, and 8 min after the administration of the dose. Images were evaluated for lesion presence, location, size, morphology, enhancement pattern, conspicuity, and type. Lesion signal intensity-time curves were acquired, and lesion matching with on-site final diagnosis was performed. A determination of global lesion detection from unenhanced to contrast-enhanced and combined images was performed, and evaluations were made of the diagnostic accuracy for lesion detection and characterization. A full safety evaluation was conducted.
Significant dose-related increases in global lesion detection were noted for patients who received gadobenate dimeglumine (p < 0.04, all evaluations). The sensitivity for detection was comparable for 0.1 and 0.2 mmol/kg of gadobenate dimeglumine, and specificity was highest with the 0.1 mmol/kg dose. Higher detection scores and higher sensitivity values for lesion characterization were found for 0.1 mmol/kg of gadobenate dimeglumine compared with 0.1 mmol/kg of gadopentetate dimeglumine, although more variable specificity values were obtained. No differences in safety were observed, and no serious adverse events were reported.
Gadobenate dimeglumine is a capable diagnostic agent for MRI of the breast. Although preliminary, our results suggest that 0.1 mmol/kg of gadobenate dimeglumine may offer advantages over doses of 0.05 and 0.2 mmol/kg of gadobenate dimeglumine and 0.1 mmol/kg of gadopentetate dimeglumine for breast lesion detection and characterization.
本研究旨在评估三种剂量的钆贝葡胺用于乳腺磁共振成像（MRI）的临床疗效及剂量反应关系，并将结果与静脉注射0.1 mmol/kg体重的钆喷酸葡胺后的结果进行比较。
对189例已知或疑似乳腺癌患者静脉推注体重0.05、0.1或0.2 mmol/kg的钆贝葡胺，或体重0.1 mmol/kg的钆喷酸葡胺。在给药前及给药后0、2、4、6和8分钟采集冠状位三维T1加权梯度回波图像。对图像进行病变存在、位置、大小、形态、强化模式、清晰度和类型的评估。获取病变信号强度-时间曲线，并将病变与现场最终诊断进行匹配。对从平扫到增强及联合图像的整体病变检测进行测定，并对病变检测和特征描述的诊断准确性进行评估。进行全面的安全性评估。
接受钆贝葡胺的患者在整体病变检测方面有显著的剂量相关增加（所有评估中p < 0.04）。0.1和0.2 mmol/kg钆贝葡胺的检测敏感性相当，0.1 mmol/kg剂量的特异性最高。与0.1 mmol/kg钆喷酸葡胺相比，0.1 mmol/kg钆贝葡胺在病变特征描述方面具有更高的检测分数和更高的敏感性值，尽管特异性值变化更大。未观察到安全性差异，也未报告严重不良事件。
钆贝葡胺是一种用于乳腺MRI的有效诊断剂。尽管是初步结果，但我们的结果表明，对于乳腺病变的检测和特征描述，0.1 mmol/kg钆贝葡胺可能比0.05和0.2 mmol/kg钆贝葡胺以及0.1 mmol/kg钆喷酸葡胺具有优势。
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