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

January 13, 2014 updated by: Jung-Eun Cheon, Seoul National University Hospital
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject who performed scheduled CT scan, mostly postoperative state of stomach cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
imaging quality
Time Frame: end of study enrollment
Two readers evaluate image quality of the abdomen CT by four-points scale
end of study enrollment
Adverse reaction
Time Frame: immediate after CT scan
immediate after CT scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNR (signal to noise ratio) / CNR (contrast to noise ratio)
Time Frame: at the end or enrollment
ROI measurement at abdominal aorta and liver
at the end or enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (ESTIMATE)

July 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Neovist IIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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