Accuracy and safety of 99mTc-labeled anti-D-dimer (DI-80B3) Fab' fragments (ThromboView®) in the diagnosis of deep vein thrombosis: A phase II study
Accuracy and safety of 99mTc-labeled anti-D-dimer (DI-80B3) Fab' fragments (ThromboView®) in the diagnosis of deep vein thrombosis: A phase II study
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DOI：
10.1016/j.thromres.2012.05.011
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发表时间：
2012-09-01
影响因子：
7.5
通讯作者：
Gerometta, Mike
中科院分区：
文献类型：
--
作者：
Douketis, James D.;Ginsberg, Jeffrey S.;Gerometta, Mike
背景：尽管有现有的诊断算法，对疑似深静脉血栓（DVT）患者的评估仍然具有挑战性。 Tc-99m 标记的 DI-DD3B6/22-80B3 Fab' 片段（Tc-99m-DI-80B3，ThromboView (R)）是一种新型诊断测试，使用对交联纤维蛋白 D-二聚体区域具有特异性的放射性标记人源化单克隆抗体片段来检测 DVT。该测试具有定位 DVT 的解剖部分和区分急性（新形成）血栓与非活动（陈旧）血栓的功能部分。方法：在一项多中心前瞻性队列试验中，我们研究了 Tc-99m-DI-80B3 对经静脉造影确诊或排除诊断的连续疑似 DVT 患者的诊断准确性和安全性。结果：我们招募了 94 名疑似 DVT 患者，其中 12 名没有患有 DVT。 Tc-99m-DI-80B3 成像，留下 82 名患者进行安全性分析。在这些患者中，有 16 名患者进行了不可评估的影像学检查（11 名静脉造影，7 名 Tc-99m-DI-80B3，均为两名患者），剩下 66 名患者进行准确性分析。 Tc-99m-DI-80B3成像耐受性良好：2名患者出现荨麻疹；没有人出现严重的不良事件。对于近端 DVT，当使用组合的 0.25 小时和 3 小时 Tc-99m-DI-80B3 图像时，敏感性（84.2%；95% 置信区间 [CI]：62.4-94.5）和特异性（97.6%；CI：83.3-99.4）最高。无论使用何种图像，远端 DVT 的准确性较低。没有足够的患者评论 Tc-99m-DI-80B3 成像对疑似复发性 DVT 的准确性。结论：Tc-99m-DI-80B3 (ThromboView (R)) 是一种针对疑似 DVT 患者的新型诊断方式，具有良好的准确性和安全性，证明在诊断准确性和临床管理研究方面进行额外的临床开发是合理的。 (C) 2012 Elsevier Ltd. 保留所有权利。
Background: The assessment of patients with suspected deep vein thrombosis (DVT) remains challenging despite current diagnostic algorithms. Tc-99m-labelled DI-DD3B6/22-80B3 Fab ' fragments (Tc-99m-DI-80B3, ThromboView (R)) is a novel diagnostic test that uses a radiolabelled humanized monoclonal antibody fragment specific for the D-dimer region of cross-linked fibrin to detect DVT. This test has an anatomic component to locate DVT and a functional component to differentiate acute (newly formed) thrombus frominactive (old) thrombus.Methods: In a multi-centre prospective cohort trial we investigated the diagnostic accuracy and safety of Tc-99m-DI-80B3 in consecutive patients with suspected DVT who had the diagnosis confirmed or excluded by venography.Results: We enrolled 94 patients with suspected DVT of whom 12 did not have Tc-99m-DI-80B3 imaging, leaving 82 patients for the safety analysis. Of these patients, there were 16 with non-evaluable imaging (11 venography, 7 Tc-99m-DI-80B3, both in two patients) leaving 66 patients for the accuracy analysis. Tc-99m-DI-80B3 imaging was well-tolerated: 2 patients developed urticaria; none developed serious adverse events. For proximal DVT, the sensitivity (84.2%; 95% confidence interval [CI]: 62.4-94.5) and specificity (97.6%; CI: 83.3-99.4) were highest when the combined 0.25-hour and 3-hour Tc-99m-DI-80B3 images were used. The accuracy was lower for distal DVT, irrespective of the images used. There were insufficient patients to comment on the accuracy of Tc-99m-DI-80B3 imaging for suspected recurrent DVT.Conclusions: Tc-99m-DI-80B3 (ThromboView (R)) is a novel diagnostic modality for patients with suspected DVT with a promising accuracy and safety profile that justifies additional clinical development in diagnostic accuracy and clinical management studies. (C) 2012 Elsevier Ltd. All rights reserved.