Trial Condition(s):
Computed Tomography, Diagnostic Imaging
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Bayer Identifier:
91462
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Jaslok Hospital and Research Centre Mumbai-400026, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations John Hopkins Outpatient Center Baltimore, United States, 21287 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tallahassee Diagnostic Imaging Tallahassee, United States, 32308 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NYU Langone Medical Center New York, United States, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brigham & Women's Hospital Boston, United States, 02115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Miami Miami, United States, 33101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Boston Medical Center Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Geisinger Medical Center Danville, United States, 17822 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUNY at Stony Brook Stony Brook, United States, 11794-8460 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiology Ltd. Tucson, United States, 85711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christian Medical Center & Hospital Tamil Nadu, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harper University Hospital Detroit, United States, 48201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109-0030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NorthShore University HealthSystem-Evanston Hospital Evanston, United States, 60201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Massachusetts General Hospital Boston, United States, 02114-2696 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical University of South Carolina Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grady Memorial Hospital Atlanta, United States, 30303 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Cleveland Clinic Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emory University Atlanta, United States, 30322 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Cardioinfantil Bogota, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de San Ignacio Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Las Vegas Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.Timeframe: post administration assessment of study images
Secondary Outcome
- The Ability of the Investigator to Make a Diagnosis Based on the CECT ImagesTimeframe: post administration assessment of study images
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.Timeframe: post administration assessment of study images
- The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT ImagesTimeframe: post administration assessment of study images
Additional Information
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