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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

Additional relevant MeSH terms:
Iopromide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014