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

Completed · Phase 2

Conditions studied: Acute Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT00519506

Run by

Agen Biomedical

People needed

61

Starts

2007-09-01

Expected to finish

2008-10-01

Last updated by the study team

2009-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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®.

You may not qualify if…

• 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.
• 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. -

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• UCSD Medical Center — San Diego, California, United States
• Henry Forde Hospital — Detroit, Michigan, United States
• Washington University School of Medicine at St. Louis — St Louis, Missouri, United States
• McMaster University Medical Center — Hamilton, Ontario, Canada
• St. Joseph's Hospital — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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