Gallium68 Ventilation/Perfusion PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sensitivity of V/Q PET/CT for PE diagnosis
研究概览
简要总结
This study evaluates the diagnostic accuracy (sensitivity, specificity) of V/Q PET/CT for the diagnosis of pulmonary embolism (PE), using CT pulmonary angiography as a reference standard.
详细描述
V/Q PET/CT imaging is now possible by substituting 99mTc with 68Ga, a positron-emitting radionuclide, using the same carrier molecules as conventional V/Q imaging. Ventilation imaging can be performed with 68Ga-carbon nanoparticles using the same synthesis device as Technegas. Perfusion imaging can be performed with 68Ga-macroaggregated albumin (68Ga-MAA).Technical advantages of PET compared to SPECT include higher sensitivity, higher spatial and temporal resolution and superior quantitative capability. This offers the opportunity to improve the accuracy of V/Q imaging in patients with suspected PE, while decreasing the acquisition time.
The aim is to perform a formal diagnostic accuracy study of V/Q PET/CT for PE, using CTPA as a reference standard.
Patients with suspected acute PE undergo CTPA and V/Q PET/CT imaging within 24 hours.
V/Q PET/CT images are not used for patients management.
After completion of inclusion, central readings of scans will be conducted independently.
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
- •Patient with suspected first episode of acute PE,
- •Age ≥ 18 years .
- •Insured patient.
排除标准
- •Patients with a clinically suspected massive PE.
- •Contraindication to contrast media (including renal insufficiency with creatinine clearance < 30 ml/min).
- •Inability to perform CTPA and V/Q PET/CT within 24 hours.
- •History of deep vein thrombosis or PE
- •Unable/unwilling to give informed consent.
- •Pregnancy / breast-feeding.
- •Patient under guardianship or curatorship
结局指标
主要结局
Sensitivity of V/Q PET/CT for PE diagnosis
时间窗: Baseline
Proportion of patients with a positive V/Q PET/CT among patients with PE according to the reference standard (CTPA).
Specificity of V/Q PET/CT for PE diagnosis
时间窗: Baseline
Proportion of patients with a negative V/Q PET/CT among patients without PE according to the reference standard (CTPA).
次要结局
未报告次要终点