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

Completed

• Conditions: Abdominal CT

• Registration Number: NCT01654354
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Primary Completion: 2012-11
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
imaging quality	end of study enrollment	Two readers evaluate image quality of the abdomen CT by four-points scale
Adverse reaction	immediate after CT scan

Secondary Outcome Measures

Name	Time	Method
SNR (signal to noise ratio) / CNR (contrast to noise ratio)	at the end or enrollment	ROI measurement at abdominal aorta and liver