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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: ThromboView


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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®. Exclusion Criteria: 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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ThromboView|Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PE, Pulmonary Embolism