Abstract
Background: The assessment of patients with suspected deep vein thrombosis (DVT) remains challenging despite current diagnostic algorithms. 99mTc-labelled DI-DD3B6/22-80B3 Fab́ 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 381-389 |
| Number of pages | 9 |
| Journal | Thrombosis Research |
| Volume | 130 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 2012 |
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Keywords
- D-dimer
- deep vein thrombosis
- diagnosis
- monoclonal antibody
- nuclear medicine imaging
ASJC Scopus subject areas
- Hematology
Cite this
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. / Douketis, James D.; Ginsberg, Jeffrey S.; Haley, Susan; Julian, Jim; Dwyer, Miriam; Levine, Mark; Eisenberg, Paul R.; Smart, Richard; Tsui, Wendy; White, Richard H; Morris, Timothy A.; Kaatz, Scott; Comp, Philip C.; Crowther, Mark A.; Kearon, Clive; Kassis, Jeannine; Bates, Shannon M.; Schulman, Sam; Desjardins, Louis; Taillefer, Raymond; Begelman, Susan M.; Gerometta, Mike.
In: Thrombosis Research, Vol. 130, No. 3, 09.2012, p. 381-389.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Accuracy and safety of 99mTc-labeled anti-D-dimer (DI-80B3) Fab' fragments (ThromboView®) in the diagnosis of deep vein thrombosis
T2 - A phase II study
AU - Douketis, James D.
AU - Ginsberg, Jeffrey S.
AU - Haley, Susan
AU - Julian, Jim
AU - Dwyer, Miriam
AU - Levine, Mark
AU - Eisenberg, Paul R.
AU - Smart, Richard
AU - Tsui, Wendy
AU - White, Richard H
AU - Morris, Timothy A.
AU - Kaatz, Scott
AU - Comp, Philip C.
AU - Crowther, Mark A.
AU - Kearon, Clive
AU - Kassis, Jeannine
AU - Bates, Shannon M.
AU - Schulman, Sam
AU - Desjardins, Louis
AU - Taillefer, Raymond
AU - Begelman, Susan M.
AU - Gerometta, Mike
PY - 2012/9
Y1 - 2012/9
N2 - Background: The assessment of patients with suspected deep vein thrombosis (DVT) remains challenging despite current diagnostic algorithms. 99mTc-labelled DI-DD3B6/22-80B3 Fab́ 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.
AB - Background: The assessment of patients with suspected deep vein thrombosis (DVT) remains challenging despite current diagnostic algorithms. 99mTc-labelled DI-DD3B6/22-80B3 Fab́ 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.
KW - D-dimer
KW - deep vein thrombosis
KW - diagnosis
KW - monoclonal antibody
KW - nuclear medicine imaging
UR - http://www.scopus.com/inward/record.url?scp=84865224241&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84865224241&partnerID=8YFLogxK
U2 - 10.1016/j.thromres.2012.05.011
DO - 10.1016/j.thromres.2012.05.011
M3 - Article
C2 - 22658414
AN - SCOPUS:84865224241
VL - 130
SP - 381
EP - 389
JO - Thrombosis Research
JF - Thrombosis Research
SN - 0049-3848
IS - 3
ER -