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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• 作者：James D. Douketis ; Jeffrey S. Ginsberg ; Susan Haley ; Jim Julian ; Miriam Dwyer ; Mark Levine ; Paul R. Eisenberg ; Richard Smart ; Wendy Tsui ; Richard H. White ; Timothy A. Morris ; Scott Kaatz ; Philip C. Comp ; Mark A. Crowther ; Clive Kearon ; Jeannine Kassis ; Shannon M. Bates ; Sam Schulman ; Louis Desjardins ; Raymond Taillefer ; et al.
• 关键词：deep vein thrombosis ; diagnosis ; nuclear medicine imaging ; D-dimer ; monoclonal antibody
• 刊名：Thrombosis Research
• 出版年：2012
• 出版时间：September, 2012
• 年：2012
• 卷：130
• 期：3
• 页码：381-389
• 全文大小：1044 K

文摘

Background

The assessment of patients with suspected deep vein thrombosis (DVT) remains challenging despite current diagnostic algorithms. ^99mTc-labelled DI-DD3B6/22-80B3 Fab¡ä fragments (^99mTc-DI-80B3, ThromboView?) 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 from inactive (old) thrombus.

Methods

In a multi-centre prospective cohort trial we investigated the diagnostic accuracy and safety of ^99mTc-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 ^99mTc-DI-80B3 imaging, leaving 82 patients for the safety analysis. Of these patients, there were 16 with non-evaluable imaging (11 venography, 7 ^99mTc-DI-80B3, both in two patients) leaving 66 patients for the accuracy analysis. ^99mTc-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 ^99mTc-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 ^99mTc-DI-80B3 imaging for suspected recurrent DVT.

Conclusions

^99mTc-DI-80B3 (ThromboView?) 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.