Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 435
- 主要终点
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.
研究概览
简要总结
This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.
Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
排除标准
- •Patients that are less than 18 years old and do not have a clinical indication for a contrast-enhanced CT of the head or body.
研究组 & 干预措施
Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
干预措施: Iopromide 370 mg I/mL (Drug)
Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously
干预措施: Iopromide 300 mg I/mL (Drug)
结局指标
主要结局
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.
时间窗: post administration assessment of study images
A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.
次要结局
- The Ability of the Investigator to Make a Diagnosis Based on the CECT Images(post administration assessment of study images)
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.(post administration assessment of study images)
- The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images(post administration assessment of study images)