3T MR Angiography of the Hepatic Vasculature: A Pilot Comparison Study of New Noncontrast Techniques to Post-contrast Technique and CT Angiography in Liver Donors.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 主要终点
- Detection Rates of the Variations of the Liver Blood Supply
研究概览
简要总结
This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.
详细描述
This study will use two Magnetic Resonance Angiography (MRA) techniques that will look at participants liver veins and arteries without giving a coloring matter (contrast) before taking the images. Investigators propose to evaluate the usefulness of these two new techniques, which do not involve exposing participants to radiation or contrast.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that fulfill the criteria for living liver donation and are evaluated for the procedure with CT and MR.
排除标准
- •Unable to give informed consent
- •Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MRI studies
- •Not suitable to undergo MRI with a gadolinium-based contrast agent because of:
- •Claustrophobia, unless patient agrees to sedation measures per institutional standard practice during MR imaging
- •Presence of metallic objects or implanted medical devices in body per institutional safety standards
- •Weight greater than that allowable by the MR table
- •Renal failure, as determined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) model based on a serum creatinine level obtained within 28 days prior to enrollment
- •Known allergy-like reaction to contrast media (gadolinium) or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR), and unwillingness to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
- •Pregnancy (if a female is of childbearing potential --defined as a premenopausal female capable of becoming pregnant --a pregnancy test should be done)
研究组 & 干预措施
Subjects who fulfill the criteria for living liver donation
Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).
干预措施: Magnetic Resonance Imaging (MRI) (Diagnostic Test)
Subjects who fulfill the criteria for living liver donation
Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).
干预措施: Compurtized Tomgraphy (CT) (Diagnostic Test)
结局指标
主要结局
Detection Rates of the Variations of the Liver Blood Supply
时间窗: Day 1
The Relative Signal Intensity of the Liver Blood Supply
时间窗: Day 1
Documentation of Acquisition Time
时间窗: Day 1
Liver Blood Supply Diameters
时间窗: Day 1
The Visibility of the Variations of the Liver Blood Supply
时间窗: Day 1
The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.
时间窗: Day 1
How Badly the Artifacts Prevented Evaluation by the Reader.
时间窗: Day 1
次要结局
- The Percentage of Examinations That Caused Adverse Events(Day 1)