Observational Study of Ultravist in Patients Requiring CECT

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: Iopromide (Ultravist, BAY86-4877)

• Registration Number: NCT01415414
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Start: 2011-09
• Primary Completion: 2012-07
• Study Completion: 2013-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11660

Inclusion Criteria

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

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Exclusion Criteria

• There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Iopromide (Ultravist, BAY86-4877)	-

Primary Outcome Measures

Name	Time	Method
Image quality evaluated by calculated CNR (Contrast to Noise Ratio)	1 day

Secondary Outcome Measures

Name	Time	Method
Image quality evaluated by calculated SNR (Signal Noise Ratio)	1 day
Radiation dose (CTDIvol)	1 day
Descriptive analysis of contrast medial injection protocol	1 day