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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Computed Tomography, Diagnostic Imaging

Intervention / Treatment
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* Drug: Iopromide 370 mg I/mL
* Drug: Iopromide 300 mg I/mL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iopromide 370 mg I/mL<br>Iopromide (Ultravist 370 mg I/mL) administered intravenously | Drug: Iopromide 370 mg I/mL<br>* Iopromide (Ultravist 370 mg I/mL) administered intravenously<br>|
| Experimental: Iopromide 300 mg I/mL<br>Iopromide (Ultravist 300 mg I/mL) administered intravenously | Drug: Iopromide 300 mg I/mL<br>* Iopromide (Ultravist 300 mg I/mL) administered intravenously<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultravist 370, CECT, CT Scan