Department of Diagnostic Imaging, Institute for Cancer Research and Treatment, Istituto per la Ricerca e la Cura del Cancro, Fondazione piemontese per l’oncologia, Candiolo, Turin, Italy.
Radiology. 2011 Feb;258(2):396-408. doi: 10.1148/radiol.10100968. Epub 2010 Dec 16.
To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol.
Institutional review board approval and patient informed consent were obtained. One hundred sixty-two women (mean age, 52.8 years ± 12.3 [standard deviation]) enrolled at 17 sites in Europe and China between July 2007 and May 2009 underwent at least one breast MR imaging examination at 1.5 T by using three-dimensional spoiled gradient-echo sequences. Of these, 151 women received both contrast agents in randomized order in otherwise identical examinations separated by more than 2 but less than 7 days. Images, acquired at 2-minute or shorter intervals after contrast agent injection, were evaluated independently by three blinded radiologists unaffiliated with enrollment centers. Histopathologic confirmation was available for all malignant lesions (n = 144), while benign lesions were confirmed either by using histopathologic examination (n = 52) or by at least 12-month diagnostic follow-up (n = 20) with mammography and/or ultrasonography. Determinations of malignant lesion detection rates and diagnostic performance (sensitivity, specificity, accuracy, positive predictive value [PPV], and negative predictive value [NPV]) were performed and compared (McNemar and Wald tests). A full safety assessment was performed.
Significant superiority for gadobenate dimeglumine was noted by readers 1, 2, and 3 for malignant lesion detection rate (91.7%, 93.1%, 94.4% vs 79.9%, 80.6%, 83.3%, respectively; P ≤ .0003). Readers 1, 2, and 3 reported significantly superior diagnostic performance (sensitivity, specificity, and accuracy) for breast cancer detection with gadobenate dimeglumine (91.1%, 94.5%, 95.2% vs 81.2%, 82.6%, 84.6%; 99.0%, 98.2%, 96.9% vs 97.8%, 96.9%, 93.8%; 98.2%, 97.8%, 96.7% vs 96.1%, 95.4%, 92.8%, respectively; P ≤ .0094) and significantly superior PPV (91.1%, 85.2%, 77.2% vs 80.7%, 75.5%, 60.9%, respectively; P ≤ .0002) and NPV (99.0%, 99.4%, 99.4% vs 97.8%, 98.0%, 98.1%, respectively; P ≤ .0003). No safety concerns were noted with either agent.
Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. © RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/).
http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1.
采用前瞻性、多中心、双盲、随机协议，对个体患者进行比较，以评价 0.1mmol/kg 剂量的钆贝葡胺与钆喷替酸葡甲胺在对比增强乳腺磁共振成像中的应用。
本研究获得了机构审查委员会的批准和患者的知情同意。2007 年 7 月至 2009 年 5 月，欧洲和中国的 17 个地点共纳入 162 例女性患者（平均年龄，52.8 岁±12.3[标准差]），均在 1.5T 磁共振成像仪上接受至少 1 次三维扰相梯度回波序列乳腺磁共振成像检查。其中，151 例女性以随机顺序分别接受了两种对比剂检查，两次检查之间的间隔时间超过 2 天但少于 7 天。注射对比剂后 2 分钟或更短时间采集的图像由 3 名不隶属于入组中心的盲法放射科医生独立进行评价。所有恶性病变（n=144）均有组织病理学证实，良性病变则通过组织病理学检查（n=52）或至少 12 个月的诊断随访（n=20）证实，随访方法包括乳腺钼靶摄影和（或）超声检查。对恶性病变检出率和诊断性能（敏感性、特异性、准确性、阳性预测值[PPV]和阴性预测值[NPV]）进行了评估和比较（McNemar 和 Wald 检验）。还进行了全面的安全性评估。
放射科医生 1、2 和 3 均认为，与钆喷替酸葡甲胺相比，钆贝葡胺在恶性病变检出率方面具有显著优势（91.7%、93.1%、94.4%比 79.9%、80.6%、83.3%；P≤.0003）。放射科医生 1、2 和 3 还报告了使用钆贝葡胺在乳腺癌检测方面具有显著更优的诊断性能（敏感性、特异性和准确性）（91.1%、94.5%、95.2%比 81.2%、82.6%、84.6%；99.0%、98.2%、96.9%比 97.8%、96.9%、93.8%；98.2%、97.8%、96.7%比 96.1%、95.4%、92.8%；P≤.0094），以及显著更优的 PPV（91.1%、85.2%、77.2%比 80.7%、75.5%、60.9%；P≤.0002）和 NPV（99.0%、99.4%、99.4%比 97.8%、98.0%、98.1%；P≤.0003）。两种对比剂均未出现安全性问题。
与钆喷替酸葡甲胺相比，钆贝葡胺在乳腺癌诊断方面具有优势。
