Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 435
- Primary Endpoint
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Intervention: Iopromide 370 mg I/mL (Drug)
Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Intervention: Iopromide 300 mg I/mL (Drug)
Outcomes
Primary Outcomes
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
- The Ability of the Investigator to Make a Diagnosis Based on the CECT Images(post administration assessment of study images)
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.(post administration assessment of study images)
- The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images(post administration assessment of study images)