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

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ClinicalTrials.gov Identifier: NCT01654354
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : January 14, 2014
Sponsor:
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



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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
Criteria

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
ClinicalTrials.gov 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)