NCT01415414

Brief Summary

It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

August 10, 2011

Last Update Submit

January 19, 2015

Conditions

Diagnostic Imaging

Keywords

Image qualityCNRSNRAbdominalPelvic

Outcome Measures

Primary Outcomes (1)

  • Image quality evaluated by calculated CNR (Contrast to Noise Ratio)

    1 day

Secondary Outcomes (3)

  • Image quality evaluated by calculated SNR (Signal Noise Ratio)

    1 day

  • Descriptive analysis of contrast medial injection protocol

    1 day

  • Radiation dose (CTDIvol)

    1 day

Study Arms (1)

Group 1

Drug: Iopromide (Ultravist, BAY86-4877)

Interventions

Iopromide (Ultravist, BAY86-4877)DRUG

CT enhancement for abdominal or pelvic scan. Generally doses of up to 1.5 g iodine per kg body weight are well tolerated

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen and pelvis, including relevant vessels

You may qualify if:

  • Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Interventions

iopromide

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 12, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

November 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

CN(1)