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

• ClinicalTrials.gov Identifier: NCT00244140
• Recruitment Status: Completed
• First Posted: October 26, 2005
• Results First Posted: July 20, 2009
• Last Update Posted: February 28, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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

Condition or disease	Intervention/treatment	Phase
Computed Tomography; Diagnostic Imaging	Drug: Iopromide 370 mg I/mL; Drug: Iopromide 300 mg I/mL	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 435 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
• Study Start Date: October 2005
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Iopromide 370 mg I/mL; Iopromide (Ultravist 370 mg I/mL) administered intravenously	Drug: Iopromide 370 mg I/mL; Iopromide (Ultravist 370 mg I/mL) administered intravenously
Experimental: Iopromide 300 mg I/mL; Iopromide (Ultravist 300 mg I/mL) administered intravenously	Drug: Iopromide 300 mg I/mL; Iopromide (Ultravist 300 mg I/mL) administered intravenously

Outcome Measures

Primary Outcome Measures :

1. The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Tucson, Arizona, United States, 85711

United States, Florida

Miami, Florida, United States, 33101

Tallahassee, Florida, United States, 32308

United States, Georgia

Atlanta, Georgia, United States, 30303

Atlanta, Georgia, United States, 30322

United States, Illinois

Evanston, Illinois, United States, 60201

United States, Maryland

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Boston, Massachusetts, United States, 02114-2696

Boston, Massachusetts, United States, 02115

Boston, Massachusetts, United States, 02118

United States, Michigan

Ann Arbor, Michigan, United States, 48109-0030

Detroit, Michigan, United States, 48201

United States, New York

New York, New York, United States, 10016

Stony Brook, New York, United States, 11794-8460

United States, Ohio

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

Danville, Pennsylvania, United States, 17822

United States, South Carolina

Charleston, South Carolina, United States, 29425

Colombia

Medellín, Antioquia, Colombia

Bogota, Colombia

Bogotá, Colombia

India

Mumbai-400026, India

Tamil Nadu, India

Korea, Republic of

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744

Seoul, Korea, Republic of, 138-736

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00244140
• Other Study ID Numbers: 91462; 309660 ( Other Identifier: company internal )
• First Posted: October 26, 2005
• Results First Posted: July 20, 2009
• Last Update Posted: February 28, 2014
• Last Verified: January 2014

Keywords provided by Bayer:

Ultravist 370; CECT; CT Scan