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

This study has been completed.
Sponsor:
Information provided by:
Agen Biomedical
ClinicalTrials.gov Identifier:
NCT00519506
First received: August 20, 2007
Last updated: April 12, 2009
Last verified: April 2009

August 20, 2007
April 12, 2009
September 2007
June 2008   (final data collection date for 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 ]
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
Complete list of historical versions of study NCT00519506 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Pulmonary Embolism
Other: ThromboView
Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
October 2008
June 2008   (final data collection date for primary outcome measure)

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. -
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00519506
CAN/US-002-II-PE
No
Not Provided
Agen Biomedical
Not Provided
Principal Investigator: Timothy Morris, MD UCSD Medical Center
Agen Biomedical
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP