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
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
In patients with suspected recurrent DVT, currently used diagnostic approaches are
problematic because they all have limitations in differentiating old disease from true
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
[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.
Study Status: Completed
Deep Vein Thrombosis
Information provided by:
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Jim Douketis, MD FRCPC., Principal Investigator
Jeff Ginsberg, MD FRCPC., Principal Investigator