Ultravist: Safety and Efficacy in Computed Tomography of Head and Body

Phase 3

Completed

• Conditions: Computed Tomography; Diagnostic Imaging
• Interventions: Drug: Iopromide 370 mg I/mL; Drug: Iopromide 300 mg I/mL

• Registration Number: NCT00244140
• Lead Sponsor: Bayer

Brief Summary

This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.

Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-24
• Study First Submitted QC: 2005-10-24
• Study First Posted: 2005-10-26
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-05-29
• Results First Submitted QC: 2009-05-29
• Results First Posted: 2009-07-20
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

• Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.

Exclusion Criteria

• Patients that are less than 18 years old and do not have a clinical indication for a contrast-enhanced CT of the head or body.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iopromide 370 mg I/mL	Iopromide 370 mg I/mL	Iopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide 300 mg I/mL	Iopromide 300 mg I/mL	Iopromide (Ultravist 300 mg I/mL) administered intravenously

Primary Outcome Measures

Name	Time	Method
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.	post administration assessment of study images	A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.

Secondary Outcome Measures

Name	Time	Method
The Ability of the Investigator to Make a Diagnosis Based on the CECT Images	post administration assessment of study images	The number of participants with diagnostic CECTs as assessed by the investigators.
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.	post administration assessment of study images	A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images	post administration assessment of study images	The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.