A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Specificity of Technegas V/Q SPECT for the Diagnosis of PE.
研究概览
简要总结
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).
详细描述
This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Subjects will be enrolled in Cohort 1 if they meet the following requirements:
- •Male or female, at least 18 years of age.
- •Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
- •Willing and able to provide informed consent.
- •Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
- •Willing and agree to complete study procedures, including follow-up safety assessments.
- •Using adequate birth control, if female and fertile.
- •If female, has a negative urine or serum pregnancy test.
- •Agrees to return for a 24-hour and 30 day follow-up safety assessment.
- •Subjects will be enrolled in Cohort 2 if they meet the above criteria AND subject is likely to have pulmonary embolism based on one or more of the following:
- •Wells Score of 7 or greater. Subjects with a Wells Score less than 7 may be enrolled in Cohort 2 if there is agreement between the investigator and the medical monitor that the subject is at high risk for PE.
- •An abnormal D-dimer test.
- •Positive Doppler ultrasound for DVT.
- •CTA is positive for PE within 24 hours of this imaging study.
排除标准
- •Has undergone imaging with Iodine-131 (I-131) within 30 days, Thallium-201 (Tl-201) or Indium-111 (In-111) within 10 days, Fluorine 18 (F-18) within 24 hours, or any other radiopharmaceutical not otherwise specified within 72 hours of this imaging study.
- •Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
- •Is a pregnant or lactating female.
- •Has received Technegas in the past.
- •Was previously enrolled in another investigational study or received an investigational drug within 30 days prior to dosing.
- •Is hemodynamically unstable.
- •Has received therapeutic dose of low molecular weight or unfractionated heparin within 24 hours prior to dosing or Tissue Plasminogen Activator (tPA) within 4 hours prior to dosing or has received treatment for PE between the time of a positive CTA, if performed, and Technegas V/Q SPECT imaging.
研究组 & 干预措施
Technegas
Technegas V SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles; approximately 1.1 milliCuries of Technegas, compared with the results of Xenon-133 ventilation scan
干预措施: Technegas V SPECT imaging (Drug)
Xenon-133
Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.
干预措施: Xenon-133 Ventilation Planar imaging (Drug)
结局指标
主要结局
Specificity of Technegas V/Q SPECT for the Diagnosis of PE.
时间窗: Prospective, 30 days follow-up
Compared to the specificity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE
时间窗: Prospective, 30 days follow-up
Compared to the sensitivity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
次要结局
- Positive Predictive Value (PPV) of Imaging for Diagnosis of PE(Prospective, 30 days follow-up)
- Likelihood Ratio for Diagnosis of PE(Prospective, 30 days follow-up)
- Negative Predictive Value (NPV) of Imaging for Diagnosis of PE(Prospective, 30 days follow-up)
- Safety of Technegas in Patients With Possible PE(Prospective, from enrollment through 30 days follow-up)
- Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE(prospective, 30 days follow-up.)