Clinical trial NCT00244140: Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Official title: Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Computed Tomography
Diagnostic Imaging
Keywords: Ultravist 370
CECT
CT Scan
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-10-26
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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 outcomes:
measure: The Ability of the Investigator to Make a Diagnosis Based on the CECT Images
timeFrame: post administration assessment of study images
measure: The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.
timeFrame: post administration assessment of study images
measure: The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images
timeFrame: post administration assessment of study images
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Miami
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Evanston
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Danville
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Medellín
country: Colombia
state: Antioquia
city: Bogota
country: Colombia
city: Bogotá
country: Colombia
city: Mumbai-400026
country: India
city: Tamil Nadu
country: India
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: