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NCT Number: NCT00244140

Ultravist: 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

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Key information

Conditions

Computed Tomography Diagnostic Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medellín, Antioquia, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iopromide 370 mg I/mL

Drug

Iopromide (Ultravist 370 mg I/mL) administered intravenously

Iopromide 300 mg I/mL

Drug

Iopromide (Ultravist 300 mg I/mL) administered intravenously

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 26, 2005
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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