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OpenTrials
Completed

NCT Number: NCT01654354

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

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

Completed

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Key information

Conditions

Abdominal CT

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

NEOVIST 370 INJ.(Iopromide 768.86mg)

Drug

Ultravist 370 INJ.(Iopromide 768.86mg)

Drug

Primary outcomes

  1. imaging quality

    Time frame: end of study enrollment

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

  2. Adverse reaction

    Time frame: immediate after CT scan

Secondary outcomes

  1. SNR (signal to noise ratio) / CNR (contrast to noise ratio)

    Time frame: at the end or enrollment

    ROI measurement at abdominal aorta and liver

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 31, 2012
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.