Acute Pulmonary EmbolismPhase 2NCT00519506
A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli
A Phase 2 study testing ThromboView in people with Acute Pulmonary Embolism, run by Agen Biomedical at 6 sites in 2 countries.
Trial summary
The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a moderate to high clinical suspicion for PE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- ThromboView
- How many people
- 61 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Sep 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Written consent by the subject to participate in the study.
- Moderate to high pre-test probability of acute pulmonary embolism.
- Positive D-dimer.
- Onset of PE symptoms occurring within the last seven days.
- Aged 18 years or older.
- Women of childbearing potential must have a negative serum pregnancy test (β-hCG) result at the time of enrollment into the study. Both male and female participants must agree to use effective contraception for the first 30 days after administration of 99mTc ThromboView®.
Who cannot join
- The subject is unwilling or unable to provide written informed consent.
- Allergy or other contraindication to intravenous iodinated contrast media.
- Prior exposure to murine, chimeric or humanized antibodies.
- Illicit intravenous drug use in the past 12 months.
- Administration of therapeutic radioiodine in the past 6 months.
- Life expectancy less than 90 days.
Show all 15Show fewer
- Previous participation in the current study.
- Current enrollment in a clinical trial involving any other investigational agent.
- Subject is unsuitable for SPECT scanning at the study Investigator's discretion (e.g. residual detectable radioactivity within the lungs due to prior imaging studies or treatment, preceding planned administration of 99mTc ThromboView®).
- Inability to perform CTPA or 99mTc ThromboView imaging, for any reason.
- Renal dysfunction: calculated creatinine clearance < 30 mL/min.
- Hepatic dysfunction: serum transaminases ≥ 3 x upper limit of normal range.
- Hepatic dysfunction: subject has history of chronic or currently active liver disease.
- Current pregnancy or lactation or conception intended within three months of enrollment.
- Subject is unsuitable for the study at the study Investigator's discretion. -
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Henry Forde Hospital
Detroit, Michigan, 48202
UC Davis Medical Center
Sacramento, California, 95817
UCSD Medical Center
San Diego, California, 92103-3872
Washington University School of Medicine at St. Louis
St Louis, Missouri, 63110
Canada2 sites
McMaster University Medical Center
Hamilton, Ontario, L8N3Z5
St. Joseph's Hospital
Hamilton, Ontario, LBN4A6
About this study
Official title: A Phase II Study to Evaluate the Efficacy of Anti-Fibrin Humanized Monoclonal Antibody(DI-DD3B6/22-80B3) Fab' Fragment (ThromboView®) Conjugated With Technetium-99m in the Detection of Pulmonary Emboli
The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a moderate to high clinical suspicion for PE.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- ThromboView
- Keywords
- Pulmonary Embolism, PE
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboViewOther
Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide estimates of the sensitivity of 99mTc ThromboView® in subjects with confirmed PE, as determined by computed tomographic pulmonary angiography (CTPA) and the specificity of 99mTc ThromboView® in subjects with PE excluded by CTPA
Measured: June 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timothy Morris, MD, Principal investigator, UCSD Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519506
- Sponsor's protocol ID
- CAN/US-002-II-PE
- Status last verified
- Apr 2009
- First submitted
- 20 Aug 2007
- Last updated
- 14 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Morris TA, Gerometta M, Yusen RD, White RH, Douketis JD, Kaatz S, Smart RC, Macfarlane D, Ginsberg JS. Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab' fragments (ThromboView). Am J Respir Crit Care Med. 2011 Sep 15;184(6):708-14. doi: 10.1164/rccm.201104-0624OC. Epub 2011 Jun 16.
PubMed 21680946
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy of Anti-Fibrin Humanized Monoclonal Antibody(DI-DD3B6/22-80B3) Fab' Fragment (ThromboView®) Conjugated With Technetium-99m in the Detection of Pulmonary Emboli
- ClinicalTrials.gov ID
- NCT00519506
- Acronym / sponsor ID
- CAN/US-002-II-PE
- Conditions
- Acute Pulmonary Embolism
- Keywords
- Pulmonary Embolism, PE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Agen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a moderate to high clinical suspicion for PE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- 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 (6 listed)
- Written consent by the subject to participate in the study.
- Moderate to high pre-test probability of acute pulmonary embolism.
- Positive D-dimer.
- Onset of PE symptoms occurring within the last seven days.
- Aged 18 years or older.
Key exclusion criteria (15 listed)
- The subject is unwilling or unable to provide written informed consent.
- Allergy or other contraindication to intravenous iodinated contrast media.
- Prior exposure to murine, chimeric or humanized antibodies.
- Illicit intravenous drug use in the past 12 months.
- Administration of therapeutic radioiodine in the past 6 months.
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 |
|---|---|---|
| ThromboViewRadiopharmaceutical, single dose, of the diagnosis of venous thromboembolism | Other | – |
Primary outcome
Provide estimates of the sensitivity of 99mTc ThromboView® in subjects with confirmed PE, as determined by computed tomographic pulmonary angiography (CTPA) and the specificity of 99mTc ThromboView® in subjects with PE excluded by CTPA
Time frame: June 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2009.
- Derived from this study: PubMed 21680946Morris TA, Gerometta M, Yusen RD, White RH, Douketis JD, Kaatz S, Smart RC, Macfarlane D, Ginsberg JS. Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab' fragments (ThromboView). Am J Respir Crit Care Med. 2011 Sep 15;184(6):708-14. doi: 10.1164/rccm.201104-0624OC. Epub 2011 Jun 16.
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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.
Timothy Morris, MD principal investigator
UCSD Medical Center
6 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 Acute Pulmonary Embolism, run by Agen Biomedical at 6 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 6 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 14 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Provide estimates of the sensitivity of 99mTc ThromboView® in subjects with confirmed PE, as determined by computed tomographic pulmonary angiography (CTPA) and the specificity of 99mTc ThromboView® in subjects with PE excluded by CTPA (time frame: June 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519506, which also lists 1 linked publication.
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 14 Apr 2009.