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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01654354
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Jung-Eun Cheon, Seoul National University Hospital

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

Condition or disease Intervention/treatment
Abdominal CT Drug: NEOVIST 370 INJ.(Iopromide 768.86mg) Drug: Ultravist 370 INJ.(Iopromide 768.86mg)

Study Type : Observational [Patient Registry]
Actual Enrollment : 104 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 8 Days
Official Title: Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT
Study Start Date : July 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Iopromide
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject who performed scheduled CT scan, mostly postoperative state of stomach cancer

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.

Responsible Party: Jung-Eun Cheon, Associate Professor in Radiology(Pediatric Radiology), Seoul National University Hospital Identifier: NCT01654354     History of Changes
Other Study ID Numbers: Neovist IIT
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Jung-Eun Cheon, Seoul National University Hospital:
Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)