NCT00519506已完成2 期
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
Agen Biomedical12 个研究点 分布在 2 个国家目标入组 61 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 12
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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®.
排除标准
- •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. -
结局指标
主要结局
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
时间窗: June 2008
次要结局
未报告次要终点
研究者
研究点 (12)
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