check_circleStudy Completed

Computed Tomography, Diagnostic Imaging

Bayer Identifier:

91462

ClinicalTrials.gov Identifier:

NCT00244140

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
  • - 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
435
Trial Dates
October 2005 - April 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Jaslok Hospital and Research CentreMumbai-400026, India
Completed
John Hopkins Outpatient CenterBaltimore, 21287, United States
Completed
Tallahassee Diagnostic ImagingTallahassee, 32308, United States
Completed
NYU Langone Medical CenterNew York, 10016, United States
Terminated
Brigham & Women's HospitalBoston, 02115, United States
Completed
University of MiamiMiami, 33101, United States
Completed
Boston Medical CenterBoston, 02118, United States
Completed
Geisinger Medical CenterDanville, 17822, United States
Completed
SUNY at Stony BrookStony Brook, 11794-8460, United States
Completed
Radiology Ltd.Tucson, 85711, United States
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Christian Medical Center & HospitalTamil Nadu, India
Terminated
Harper University HospitalDetroit, 48201, United States
Completed
University of Michigan Health SystemAnn Arbor, 48109-0030, United States
Terminated
NorthShore University HealthSystem-Evanston HospitalEvanston, 60201, United States
Completed
Massachusetts General HospitalBoston, 02114-2696, United States
Completed
Medical University of South CarolinaCharleston, 29425, United States
Completed
Grady Memorial HospitalAtlanta, 30303, United States
Completed
The Cleveland ClinicCleveland, 44195, United States
Completed
Emory UniversityAtlanta, 30322, United States
Terminated
Fundación CardioinfantilBogota, Colombia
Terminated
Hospital Universitario de San IgnacioBogotá, Colombia
Terminated
Hospital Universitario de San IgnacioBogotá, Colombia
Terminated
Clínica Las VegasMedellín, 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 images
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The Ability of the Investigator to Make a Diagnosis Based on the CECT Images
    date_rangeTime Frame:
    post administration assessment of study images
    enhanced_encryption
    Safety Issue:
    No
  • 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 images
    enhanced_encryption
    Safety Issue:
    No
  • The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images
    date_rangeTime Frame:
    post administration assessment of study images
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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