Imaging of deep venous thrombosis in patients using a radiolabelled anti-D-dimer Fab′ fragment (99mTc-DI-DD3B6/22-80B3): results of a phase I trial

Macfarlane, David, Socrates, Angelides, Eisenberg, Paul, Larcos, George, Roach, Paul, Gerometta, Michael, Smart, Richard, Tsui, Wendy and Scott, Andrew M. (2009) Imaging of deep venous thrombosis in patients using a radiolabelled anti-D-dimer Fab′ fragment (99mTc-DI-DD3B6/22-80B3): results of a phase I trial. European Journal of Nuclear Medicine and Molecular Imaging, 36 2: 250-259. doi:10.1007/s00259-008-0934-7

Author Macfarlane, David
Socrates, Angelides
Eisenberg, Paul
Larcos, George
Roach, Paul
Gerometta, Michael
Smart, Richard
Tsui, Wendy
Scott, Andrew M.
Title Imaging of deep venous thrombosis in patients using a radiolabelled anti-D-dimer Fab′ fragment (99mTc-DI-DD3B6/22-80B3): results of a phase I trial
Journal name European Journal of Nuclear Medicine and Molecular Imaging   Check publisher's open access policy
ISSN 1619-7070
Publication date 2009-02
Year available 2008
Sub-type Article (original research)
DOI 10.1007/s00259-008-0934-7
Volume 36
Issue 2
Start page 250
End page 259
Total pages 9
Editor Ignasi Carrio
Place of publication Berlin / Heidelberg
Publisher Springer
Collection year 2009
Language eng
Subject C1
110320 Radiology and Organ Imaging
110313 Nuclear Medicine
Abstract Purpose 99mTc-DI-DD3B6/22-80B3 (ThromboView®, hereafter abbreviated to 99mTc-DI-80B3 Fab′) is a radiolabelled humanised monoclonal Fab′ fragment with affinity and specificity for D-dimer domains of cross-linked fibrin. Detection of thromboembolic events has been demonstrated in canine models. The study objectives were evaluation of safety and characterisation of biodistribution, immunogenicity and pharmacokinetic profile of increasing doses of 99mTc-DI-80B3 Fab′ in subjects with acute lower-limb DVT. Methods Twenty-six patients with acute lower limb DVT were enrolled. Of these, 21 received a single intravenous dose of 0.5 mg (n = 6), 1.0 mg (n = 9) or 2 mg (n = 6) 99mTc-DI-80B3 Fab′. Blood and urine samples and gamma camera images were collected to 24 h after administration for pharmacokinetic and dosimetry analysis. Vital signs, electrocardiography, hematological and biochemical data and human anti-human antibody (HAHA) levels were monitored for up to 30 days following administration. Patients were assigned to either planar or single photon emission computed tomographic (SPECT) imaging of the thorax at 4 h following injection. Results Thirty-five adverse events were reported in 15 of the 21 subjects. Those deemed possibly related to administration of 99mTc-DI-80B3 Fab′ included mild hypertension, mild elevation of LD (lactate dehydrogenase) and moderate elevation of ALT (alanine transaminase). HAHA assays remained negative. Pharmacokinetics and organ dosimetry were comparable to prior normal volunteer data. Localisation of Thromboview® to sites of known thrombus was evident as early as 30 min post-injection. Conclusions In subjects with acute DVT, 99mTc-DI-80B3 Fab′ was well tolerated with favourable characteristics for the detection of acute venous thrombosis.
Q-Index Code C1
Q-Index Status Confirmed Code

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2009 Higher Education Research Data Collection
School of Medicine Publications
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 8 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 11 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Fri, 12 Jun 2009, 14:50:13 EST by Siona Saplos on behalf of Research Management Office