Individually Optimized Uniform Contrast Enhancement in CT Angiography for the Diagnosis of Pulmonary Thromboembolic Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan
研究概览
简要总结
Examine the feasibility and efficacy of individually optimized uniform contrast enhancement in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.
详细描述
Patient characteristics, qualitative image quality scores, and quantitative contrast enhancement and CNR will be described using mean values and standard deviations for continuous variables, and frequencies and percent for categorical variables. Difference between the two patient groups will be compared using Wilcoxon signed rank tests and chi-square statistics for continuous and categorical variables, respectively. All statistical tests will be performed at a significance level of 0.05.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients 18 years old or older
- •Patients who have been recommended for CTPA scan for the diagnosis of pulmonary; thromboembolic disease (PE) in the Department of Diagnostic Radiology and Nuclear Medicine at the University of Maryland-Patients whose body mass index (BMI) is greater than 30 kg/m
- •Patients whose body mass index (BMI) is greater than 30 kg/m2
- •Patients who signed the University of Maryland Medical Center Consent for Intravenous Contrast Administration
排除标准
- •Pregnant or breast-feeding women; Female participants of childbearing age (10 - 60 years) will be screened for their pregnancy status prior to study registration, by following the Department of Diagnostic Radiology and Nuclear Medicine CLINICAL STANDARD Procedure DI-AOP-003 "Pregnancy Screening Documentation"; - Patients with decreased renal function34-
- •This is evaluated by blood work checked within 30 days prior to the CTPA scan with contrast. Patients cannot receive contrast if their BUN index is not within [7-20] or creatinine is not within [0.5 - 1.4] mg/dL
- •Patients with decreased renal function34-
- •This is evaluated by blood work checked within current admission for inpatients or within 30 days for outpatients prior to the CTPA scan with contrast. Patients cannot receive contrast if their serum creatinine level exceeds 2.0 mg/dL
- •Patients with known moderate or severe allergic reactions to contrast, including but not limited to: shortness of breath, a change in baseline vital signs, such as a change in blood pressure, tachycardia, increased respirations that can progress to major respiratory distress, laryngeal edema, bronchospasm, arrhythmias, convulsions, and cardiopulmonary arrest.
结局指标
主要结局
Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan
时间窗: 1 year
The primary endpoint is to study the feasibility( bi-phasic vs. singular pahse contrast injection (by comparison analysis)) of individually optimized bi-phasic contrast injection for CTPA scan.
Efficacy of PE diagnosis with CTPA imaging
时间窗: 1 year
To quantify the efficacy (by comparison analysis) of PE diagnosis of this new contrast injection protocol in terms of reduced frequency of non-diagnostic CTPA image vs. standard of care procedures.
次要结局
- # of patients who receive contrast enhancement and CNR of CTPA scans(1 year)
研究者
Department of Radiation Oncology
Site Investigator
University of Maryland, Baltimore