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.
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.
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.