check_circleStudy Completed
Computed Tomography, Diagnostic Imaging
Bayer Identifier:
91462
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
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
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
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
435Trial Dates
October 2005 - April 2008Phase
Phase 3Could I Receive a placebo
NoProducts
Ultravist (Iopromide, BAY86-4877)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Jaslok Hospital and Research Centre | Mumbai-400026, India |
Completed | John Hopkins Outpatient Center | Baltimore, 21287, United States |
Completed | Tallahassee Diagnostic Imaging | Tallahassee, 32308, United States |
Completed | NYU Langone Medical Center | New York, 10016, United States |
Terminated | Brigham & Women's Hospital | Boston, 02115, United States |
Completed | University of Miami | Miami, 33101, United States |
Completed | Boston Medical Center | Boston, 02118, United States |
Completed | Geisinger Medical Center | Danville, 17822, United States |
Completed | SUNY at Stony Brook | Stony Brook, 11794-8460, United States |
Completed | Radiology Ltd. | Tucson, 85711, United States |
Completed | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Seoul National University Hospital | Seoul, 110-744, Korea, Republic Of |
Completed | Christian Medical Center & Hospital | Tamil Nadu, India |
Terminated | Harper University Hospital | Detroit, 48201, United States |
Completed | University of Michigan Health System | Ann Arbor, 48109-0030, United States |
Terminated | NorthShore University HealthSystem-Evanston Hospital | Evanston, 60201, United States |
Completed | Massachusetts General Hospital | Boston, 02114-2696, United States |
Completed | Medical University of South Carolina | Charleston, 29425, United States |
Completed | Grady Memorial Hospital | Atlanta, 30303, United States |
Completed | The Cleveland Clinic | Cleveland, 44195, United States |
Completed | Emory University | Atlanta, 30322, United States |
Terminated | Fundación Cardioinfantil | Bogota, Colombia |
Terminated | Hospital Universitario de San Ignacio | Bogotá, Colombia |
Terminated | Hospital Universitario de San Ignacio | Bogotá, Colombia |
Terminated | Clínica Las Vegas | Medellín, Colombia |
Primary Outcome
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.date_rangeTime Frame:post administration assessment of study imagesenhanced_encryptionNoSafety Issue:
Secondary Outcome
- The Ability of the Investigator to Make a Diagnosis Based on the CECT Imagesdate_rangeTime Frame:post administration assessment of study imagesenhanced_encryptionNoSafety Issue:
- The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.date_rangeTime Frame:post administration assessment of study imagesenhanced_encryptionNoSafety Issue:
- The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Imagesdate_rangeTime Frame:post administration assessment of study imagesenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2