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Sponsored by: |
Agen Biomedical |
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Information provided by: | Agen Biomedical |
ClinicalTrials.gov Identifier: | NCT00123734 |
The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging.
The diagnosis of DVT remains problematic in:
In patients with suspected first DVT who have a moderate or high PTP and a normal CUS, DVT occurs in up to 10% of cases. Thus, additional diagnostic testing is required, such as venography or serial CUS, so that DVT is not missed, but these approaches are costly and invasive.
In patients with suspected recurrent DVT, currently used diagnostic approaches are problematic because they all have limitations in differentiating old disease from true recurrent disease.
CUS is technically difficult in selected patients, particularly those who are obese.
Contrast venography is the gold standard diagnostic test for DVT to which all other diagnostic venous imaging modalities for DVT are compared and judged. The Food and Drug Administration (FDA) requires that a new diagnostic test for DVT be assessed against venography.
[99mTc] ThromboView® is a novel diagnostic test based on a 99mTc-labeled monoclonal antibody specific for D-dimer fragments of cross-linked fibrin that are found in acute DVT. After intravenous injection of [99mTc] ThromboView®, there is uptake of the monoclonal antibody by acute, D-dimer rich, venous thrombi. This is visualized with nuclear medicine imaging as an area of increased radioisotope activity that corresponds to the location of DVT.
Based on the biologic and imaging characteristics of [99mTc] ThromboView®, this diagnostic test has the potential to:
The present study is the first phase II clinical trial of [99mTc] ThromboView® in patients with suspected initial or recurrent DVT in whom DVT has been confirmed or excluded by venography. A phase II clinical trial to investigate the diagnostic accuracy of [99mTc] ThromboView® is justified because:
Condition | Intervention | Phase |
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Deep Vein Thrombosis |
Drug: ThromboView |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Clinical Trial to Evaluate the Accuracy of Anti-Fibrin Humanized Monoclonal Antibody (DI-DD3B6/22-80B3) Fab' Protein Fragment (ThromboView) Conjugated With Technetium-99m in the Detection of Deep Vein Thrombosis |
Estimated Enrollment: | 180 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Medical Centre | |
San Diego, California, United States, 82103-9378 | |
UC Davis | |
Sacramento, California, United States, 95817 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Oklahoma | |
University of Oklahoma, Health Sciences Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
Canada, Ontario | |
McMaster University, Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Henderson General Site | |
Hamilton, Ontario, Canada, L8V1C3 | |
Hamilton General Hospital | |
Hamilton, Ontario, Canada, L8L 2X2 | |
St. Joseph's Healthcare | |
Hamilton, Ontario, Canada, L8N4A6 | |
Canada, Quebec | |
Hotel-Dieu Du CHUM | |
Montreal, Quebec, Canada, H2W1T8 | |
Hopital Maisonneuve-Rosemont | |
Montreal, Quebec, Canada, H1T 2M4 | |
Centre hospitalier de L'Universite Laval | |
Sainte-Foy, Quebec, Canada, G1V 4G2 |
Principal Investigator: | Jim Douketis, MD FRCPC | Hamilton Health Sciences |
Principal Investigator: | Jeff Ginsberg, MD FRCPC | Hamilton Health Sciences |
Study ID Numbers: | CAN/US-001-II-DVT |
Study First Received: | July 24, 2005 |
Last Updated: | February 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00123734 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Antibodies, Monoclonal Antibodies Embolism and Thrombosis Embolism |
Vascular Diseases Venous Thrombosis Thrombosis Immunoglobulins |
Cardiovascular Diseases |