Deep Vein ThrombosisPhase 2NCT00123734
Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis
A Phase 2 study testing ThromboView in people with Deep Vein Thrombosis, run by Agen Biomedical at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- ThromboView
- How many people
- 94 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Mar 2005to May 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada7 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
McMaster University, Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare
Hamilton, Ontario, L8N4A6
Henderson General Site
Hamilton, Ontario, L8V1C3
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Hotel-Dieu Du CHUM
Montreal, Quebec, H2W1T8
Centre hospitalier de L'Universite Laval
Sainte-Foy, Quebec, G1V 4G2
United States5 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104
UC Davis
Sacramento, California, 95817
UCSD Medical Centre
San Diego, California, 82103-9378
About this 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
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:
Read more
- 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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- ThromboView
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboViewDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT
Measured: May 2007
To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT.
Measured: September 2005
Secondary outcomes (6)
To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded
Measured: May 2007
To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT
Measured: May 2007
To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT
Measured: May 2007
To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT
Measured: May 2007
To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT
Measured: 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
Measured: May 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startMar 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Douketis, MD FRCPC, Principal investigator, Hamilton Health Sciences CorporationJeff Ginsberg, MD FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123734
- Sponsor's protocol ID
- CAN/US-001-II-DVT
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2005
- Last updated
- 24 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00123734
- Acronym / sponsor ID
- CAN/US-001-II-DVT
- Conditions
- Deep Vein Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Agen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- May 2006
- First posted
- 26 Jul 2005 (estimated)
- Results
- Posted 24 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboView | Drug | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Douketis, MD FRCPC principal investigator
Hamilton Health Sciences Corporation
Jeff Ginsberg, MD FRCPC principal investigator
Hamilton Health Sciences Corporation
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ThromboView in people with Deep Vein Thrombosis, run by Agen Biomedical at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT (time frame: May 2007). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2009; AzTrials last refreshed its copy on 7 Nov 2026.