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
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
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
435
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Tallahassee, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Evanston, Illinois, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Boston, Massachusetts, United States
...and 13 more locations
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.
Time frame: post administration assessment of study images
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.
Time frame: 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.
Time frame: 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.
Time frame: post administration assessment of study images
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.