Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
2 other identifiers
interventional
435
4 countries
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2005
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 24, 2005
CompletedFirst Posted
Study publicly available on registry
October 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
July 20, 2009
CompletedFebruary 28, 2014
January 1, 2014
2.5 years
October 24, 2005
May 29, 2009
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Iopromide 370 mg I/mL
EXPERIMENTALIopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide 300 mg I/mL
EXPERIMENTALIopromide (Ultravist 300 mg I/mL) administered intravenously
Interventions
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Eligibility Criteria
You may qualify if:
- Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Tucson, Arizona, 85711, United States
Unknown Facility
Miami, Florida, 33101, United States
Unknown Facility
Tallahassee, Florida, 32308, United States
Unknown Facility
Atlanta, Georgia, 30303, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Evanston, Illinois, 60201, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Boston, Massachusetts, 02114-2696, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Ann Arbor, Michigan, 48109-0030, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Stony Brook, New York, 11794-8460, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Danville, Pennsylvania, 17822, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Medellín, Antioquia, Colombia
Unknown Facility
Bogotá, Colombia
Unknown Facility
Mumbai-400026, India
Unknown Facility
Tamil Nadu, India
Unknown Facility
Seoul, Seoul Teugbyeolsi, 110-744, South Korea
Unknown Facility
Seoul, 138-736, South Korea
MeSH Terms
Interventions
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2005
First Posted
October 26, 2005
Study Start
October 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
February 28, 2014
Results First Posted
July 20, 2009
Record last verified: 2014-01