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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung-Eun Cheon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01654354
First received: July 20, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Abdominal CT
Drug: NEOVIST 370 INJ.(Iopromide 768.86mg)
Drug: Ultravist 370 INJ.(Iopromide 768.86mg)
Phase 4

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • imaging quality [ Time Frame: end of study enrollment ] [ Designated as safety issue: No ]
    Two readers evaluate image quality of the abdomen CT by four-points scale

  • Adverse reaction [ Time Frame: immediate after CT scan ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • SNR (signal to noise ratio) / CNR (contrast to noise ratio) [ Time Frame: at the end or enrollment ] [ Designated as safety issue: No ]
    ROI measurement at abdominal aorta and liver


Enrollment: 104
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: July 20, 2012
Last Updated: January 13, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 15, 2014