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A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli

Sponsor
Agen Biomedical (Industry)
Overall Status
Completed
CT.gov ID
NCT00519506
Collaborator
(none)
61
Enrollment
6
Locations
13
Duration (Months)
10.2
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: ThromboView
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Outcome Measures

Primary Outcome Measures

  1. 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 [June 2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Written consent by the subject to participate in the study.

  2. Moderate to high pre-test probability of acute pulmonary embolism.

  3. Positive D-dimer.

  4. Onset of PE symptoms occurring within the last seven days.

  5. Aged 18 years or older.

  6. 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®.

Exclusion Criteria:

  1. The subject is unwilling or unable to provide written informed consent.

  2. Allergy or other contraindication to intravenous iodinated contrast media.

  3. Prior exposure to murine, chimeric or humanized antibodies.

  4. Illicit intravenous drug use in the past 12 months.

  5. Administration of therapeutic radioiodine in the past 6 months.

  6. Life expectancy less than 90 days.

  7. Previous participation in the current study.

  8. Current enrollment in a clinical trial involving any other investigational agent.

  9. 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®).

  10. Inability to perform CTPA or 99mTc ThromboView imaging, for any reason.

  11. Renal dysfunction: calculated creatinine clearance < 30 mL/min.

  12. Hepatic dysfunction: serum transaminases ≥ 3 x upper limit of normal range.

  13. Hepatic dysfunction: subject has history of chronic or currently active liver disease.

  14. Current pregnancy or lactation or conception intended within three months of enrollment.

  15. Subject is unsuitable for the study at the study Investigator's discretion. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC Davis Medical Center Sacramento California United States 95817
2 UCSD Medical Center San Diego California United States 92103-3872
3 Henry Forde Hospital Detroit Michigan United States 48202
4 Washington University School of Medicine at St. Louis St. Louis Missouri United States 63110
5 McMaster University Medical Center Hamilton Ontario Canada L8N3Z5
6 St. Joseph's Hospital Hamilton Ontario Canada LBN4A6

Sponsors and Collaborators

  • Agen Biomedical

Investigators

  • Principal Investigator: Timothy Morris, MD, UCSD Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00519506
Other Study ID Numbers:
  • CAN/US-002-II-PE
First Posted:
Aug 22, 2007
Last Update Posted:
Apr 14, 2009
Last Verified:
Apr 1, 2009
Keywords provided by , ,
Pulmonary Embolism
PE
Additional relevant MeSH terms:
Pulmonary Embolism
Embolism

Study Results

No Results Posted as of Apr 14, 2009