Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Diagnostic Quality of Images
研究概览
简要总结
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 88 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled to receive TAVR abdominal CT
排除标准
- •cannot undergo CT scan
- •Allergy to intravenous contrast not controlled by steroids or benadryl
研究组 & 干预措施
Cohort 1
A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).
干预措施: Iodinated Contrast Agent (Omnipaque) (Combination Product)
Cohort 1
A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).
干预措施: Dual Energy CT (Device)
Cohort 2
If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.
干预措施: Iodinated Contrast Agent (Omnipaque) (Combination Product)
Cohort 2
If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.
干预措施: Dual Energy CT (Device)
结局指标
主要结局
Diagnostic Quality of Images
时间窗: 18-24 months
5-point Likert Scale
次要结局
未报告次要终点
研究者
Vikas Kundra
Chief of Oncologic Imaging, Dept. of Radiology and Nuclear Medicine
University of Maryland, Baltimore
