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

Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body

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

Study Overview

• Status: Completed
• Conditions: Diagnostic Imaging; Computed Tomography
• Intervention / Treatment: Drug: Iopromide 370 mg I/mL; Drug: Iopromide 300 mg I/mL

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 Type: Interventional
• Enrollment (Actual): 435
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Bogota, Colombia
  • Bogotá, Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
• India
  • Mumbai-400026, India
  • Tamil Nadu, India
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
  • Florida
    • Miami, Florida, United States, 33101
    • Tallahassee, Florida, United States, 32308
  • Georgia
    • Atlanta, Georgia, United States, 30303
    • Atlanta, Georgia, United States, 30322
  • Illinois
    • Evanston, Illinois, United States, 60201
  • Maryland
    • Baltimore, Maryland, United States, 21287
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
    • Boston, Massachusetts, United States, 02114-2696
    • Boston, Massachusetts, United States, 02115
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0030
    • Detroit, Michigan, United States, 48201
  • New York
    • New York, New York, United States, 10016
    • Stony Brook, New York, United States, 11794-8460
  • Ohio
    • Cleveland, Ohio, United States, 44195
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
  • South Carolina
    • Charleston, South Carolina, United States, 29425

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: October 24, 2005
• First Submitted That Met QC Criteria: October 24, 2005
• First Posted (Estimate): October 26, 2005

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: CT Scan; Ultravist 370; CECT
• Other Study ID Numbers: 91462; 309660 (Other Identifier: company internal)