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CompletedNCT01654354Updated Jan 14, 2014

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

An observational study in Abdominal CT, sponsored by Seoul National University Hospital. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-14.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
104
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Abdominal CT

Keywords

  • Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
104 participants (actual)
Target follow-up
8 Days
Patient registry
Yes

Interventions

  • DrugNEOVIST 370 INJ.(Iopromide 768.86mg)
  • DrugUltravist 370 INJ.(Iopromide 768.86mg)
06

What researchers measure

Primary outcomes

  1. imaging quality

    Two readers evaluate image quality of the abdomen CT by four-points scale

    Time frame: end of study enrollment

  2. Adverse reaction

    Time frame: immediate after CT scan

Secondary outcomes

  1. SNR (signal to noise ratio) / CNR (contrast to noise ratio)

    ROI measurement at abdominal aorta and liver

    Time frame: at the end or enrollment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01654354
Lead sponsor
Seoul National University Hospital
Responsible party
Jung-Eun Cheon (Associate Professor in Radiology(Pediatric Radiology), Seoul National University Hospital) — Principal investigator
First posted
Jul 31, 2012
Start date
Jul 2012
Primary completion
Nov 2012
Completion
Dec 2013
Last update
Jan 14, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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