Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123734
Status:
COMPLETED
Last Update Posted:
2009-08-24
First Post:
2005-07-24
Brief Title:
Clinical Trial to Evaluate the Accuracy of 99mTc ThromboView in the Detection of Deep Vein Thrombosis
Sponsor:
Agen Biomedical
Organization:
Agen Biomedical
Study Overview
Official Title:
Phase II Clinical Trial to Evaluate the Accuracy of Anti-Fibrin Humanized Monoclonal Antibody DI-DD3B622-80B3 Fab Protein Fragment ThromboView Conjugated With Technetium-99m in the Detection of Deep Vein Thrombosis
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None