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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
  Purpose

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 Intervention Phase
Acute Pulmonary Embolism
Other: ThromboView
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Agen Biomedical:

Primary Outcome Measures:
  • 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 ]

Enrollment: 61
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: ThromboView
    Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519506

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
UCSD Medical Center
San Diego, California, United States, 92103-3872
United States, Michigan
Henry Forde Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine at St. Louis
St. Louis, Missouri, United States, 63110
Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N3Z5
St. Joseph's Hospital
Hamilton, Ontario, Canada, LBN4A6
Sponsors and Collaborators
Agen Biomedical
Investigators
Principal Investigator: Timothy Morris, MD UCSD Medical Center
  More Information

No publications provided by Agen Biomedical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00519506     History of Changes
Other Study ID Numbers: CAN/US-002-II-PE
Study First Received: August 20, 2007
Last Updated: April 12, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Agen Biomedical:
Pulmonary Embolism
PE

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014