Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With U... | NCT01654354

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

NCT01654354

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 14, 2014Estimated

Enrollment

104Actual

Phase

Not provided

Conditions

Abdominal CT

Interventions

NEOVIST 370 INJ.(Iopromide 768.86mg)
Ultravist 370 INJ.(Iopromide 768.86mg)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 20, 2012

First Submission Date that Met QC Criteria

Jul 30, 2012

First Posted Date

Jul 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung-Eun Cheon, Associate Professor in Radiology(Pediatric Radiology), Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Type	Description	Arm Group Labels	Other Names
NEOVIST 370 INJ.(Iopromide 768.86mg)	Drug
Ultravist 370 INJ.(Iopromide 768.86mg)	Drug