临床试验/NCT01654354

NCT01654354已完成不适用

Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT

Seoul National University Hospital0 个研究点目标入组 104 人开始时间: 2012年7月最近更新: 2014年1月14日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Seoul National University Hospital
入组人数: 104
主要终点: imaging quality

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT

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: 20 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged 20 to 75 years old.
•Subjects who need CT scan
•Subjects who are willing to participate in the study and to write the informed consent form.

排除标准

•Subjects with severe hepatopathy whose AST or ALT ≥ 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT ≥ UNL(upper normal limit) X 3
•Severe disorder of thyroid gland
•homocystinuria
•pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods
•Participation in another clinical trial within 30days of enrollment into this study.

结局指标

主要结局

imaging quality

时间窗: end of study enrollment

Two readers evaluate image quality of the abdomen CT by four-points scale

Adverse reaction

时间窗: immediate after CT scan

次要结局

SNR (signal to noise ratio) / CNR (contrast to noise ratio)(at the end or enrollment)

研究者

发起方

Seoul National University Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Jung-Eun Cheon

Associate Professor in Radiology(Pediatric Radiology)

Seoul National University Hospital

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