Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis

This study has been completed.
Sponsor:
Information provided by:
Agen Biomedical
ClinicalTrials.gov Identifier:
NCT00123734
First received: July 24, 2005
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Deep Vein Thrombosis
Drug: ThromboView
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Agen Biomedical:

Primary Outcome Measures:
  • To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT. [ Time Frame: September 2005 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: March 2005
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult man or woman, aged ≥18 years, presenting with suspected lower-limb initial or recurrent DVT.
  • Moderate or high pre-test probability (PTP) for DVT.
  • Onset of symptoms occurred within the last 7 days.
  • Women of childbearing potential to have a negative pregnancy test as determined by measuring serum β-hCG levels at time of study enrolment.

Exclusion Criteria:

  • Receiving anticoagulant therapy at therapeutic doses for >3 days.
  • Life expectancy <3 months.
  • Patient with a renal transplant.
  • Renal dysfunction: serum creatinine >1.5x upper limit of normal range.
  • Hepatic dysfunction: serum transaminases >3x upper limit of normal range.
  • Current pregnancy or lactation; or conception intended within 90 days of enrolment
  • Of childbearing potential and unwilling to use adequate contraception for 30 days following enrolment
  • Unable to undergo lower limb ascending venography on symptomatic leg(s).
  • Allergy or other contraindication to intravenous contrast dye.
  • Prior exposure to murine or humanized antibodies.
  • Prior imaging studies with: I131 within the last month; In111 or Ga67 within the last 2 weeks; Tc99m labelled RBCs, WBCs or albumin within the last 48 hours; Tc99m or F18 within the last 24 hours; prior non-imaging, non-therapeutic nuclear medicine studies with I131 (eg., 24-hour RAI uptake) within the last 2 weeks.
  • Previous participation in the present study.
  • Geographic inaccessibility that precludes follow-up visits.
  • Patient is unwilling or unable to provide informed consent.
  • Patient is unsuitable for the study, at the Study Investigator's discretion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123734

Locations
United States, California
UC Davis
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
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
Sponsors and Collaborators
Agen Biomedical
Investigators
Principal Investigator: Jim Douketis, MD FRCPC Hamilton Health Sciences Corporation
Principal Investigator: Jeff Ginsberg, MD FRCPC Hamilton Health Sciences Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00123734     History of Changes
Other Study ID Numbers: CAN/US-001-II-DVT
Study First Received: July 24, 2005
Results First Received: July 9, 2009
Last Updated: July 9, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014