Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis
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|ClinicalTrials.gov Identifier: NCT00123734|
Recruitment Status : Completed
First Posted : July 26, 2005
Results First Posted : August 24, 2009
Last Update Posted : August 24, 2009
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:
- patients with suspected first DVT who have a moderate or high pre-test probability (PTP) for DVT and a normal compression ultrasound (CUS);
- patients with suspected recurrent DVT; and
- patients in whom CUS or contrast venography is technically difficult or not feasible due to patient characteristics.
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:
- identify small non-occlusive proximal DVT or distal DVT in patients with a moderate or high PTP and normal CUS;
- differentiate old from new DVT in patients with suspected recurrent DVT;
- diagnose or exclude DVT in patients in whom CUS is not technically feasible; and
- provide an alternative to venography that is non-invasive, has no contrast-related toxicity and is easily administered.
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:
- ThromboView® was well tolerated, with no significant toxicity in studies involving animals and healthy volunteers; and
- it has shown promise in Phase I trials as a non-invasive diagnostic test for acute DVT.
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis||Drug: ThromboView||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||May 2006|
- To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT [ Time Frame: May 2007 ]
- To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT. [ Time Frame: September 2005 ]
- To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded [ Time Frame: May 2007 ]
- To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT [ Time Frame: May 2007 ]
- To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT [ Time Frame: May 2007 ]
- To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT [ Time Frame: May 2007 ]
- To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT [ Time Frame: May 2007 ]
- To Provide Estimates of the Sensitivity and Specificity of [99mTc] ThromboView® for DVT at the 1-Hour and 3-Hour Imaging Time Points [ Time Frame: May 2007 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123734
|United States, California|
|Sacramento, California, United States, 95817|
|UCSD Medical Centre|
|San Diego, California, United States, 82103-9378|
|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|
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|McMaster University, Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N4A6|
|Henderson General Site|
|Hamilton, Ontario, Canada, L8V1C3|
|Montreal, Quebec, Canada, H1T 2M4|
|Hotel-Dieu Du CHUM|
|Montreal, Quebec, Canada, H2W1T8|
|Centre hospitalier de L'Universite Laval|
|Sainte-Foy, Quebec, Canada, G1V 4G2|
|Principal Investigator:||Jim Douketis, MD FRCPC||Hamilton Health Sciences Corporation|
|Principal Investigator:||Jeff Ginsberg, MD FRCPC||Hamilton Health Sciences Corporation|