NCT02100358已完成不适用
Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of positive cases of acute cholecystitis
研究概览
简要总结
Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis.
详细描述
Primary Objective:
To determine the accuracy of fMRC in evaluating patients with suspected cholecystitis.
Secondary Objective:
To compare the results of fMRC with conventional hepatobiliary scintigraphy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years of age or older
- •Symptoms of right upper quadrant pain with ambiguous US (and/or CT) findings
- •Standard of care nuclear medicine hepatobiliary scan to rule out acute cholecystitis -
排除标准
- •Scheduled for emergent surgery, or is otherwise determined by the Investigator that the subject is clinically unsuitable for the study
- •Glomerular filtration rate (GFR) below 60 mL/min/1.73m2
- •Total bilirubin above 3.0 mg/dL
- •Inability to provide informed consent (altered or diminished mental status)
- •Allergic to morphine
- •Known or suspected hypersensitivity to gadolinium-based agents
- •The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), penile implants, inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
- •Pregnant or breast-feeding -
结局指标
主要结局
Number of positive cases of acute cholecystitis
时间窗: 2 years
The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging
次要结局
未报告次要终点
研究者
研究点 (1)
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