Ultravist: Safety and Efficacy in Computed Tomography of Head and Body

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00244140
First received: October 24, 2005
Last updated: January 28, 2014
Last verified: January 2014
  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


Condition Intervention Phase
Computed Tomography
Diagnostic Imaging
Drug: Iopromide 370 mg I/mL
Drug: Iopromide 300 mg I/mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. [ Time Frame: post administration assessment of study images ] [ Designated as safety issue: No ]
    A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.


Secondary Outcome Measures:
  • The Ability of the Investigator to Make a Diagnosis Based on the CECT Images [ Time Frame: post administration assessment of study images ] [ Designated as safety issue: No ]
    The number of participants with diagnostic CECTs as assessed by the investigators.

  • The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. [ Time Frame: post administration assessment of study images ] [ Designated as safety issue: No ]
    A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.

  • The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images [ Time Frame: post administration assessment of study images ] [ Designated as safety issue: No ]
    The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.


Enrollment: 435
Study Start Date: October 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Drug: Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Experimental: Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Drug: Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244140

  Show 24 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00244140     History of Changes
Other Study ID Numbers: 91462, 309660
Study First Received: October 24, 2005
Results First Received: May 29, 2009
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Ultravist 370
CECT
CT Scan

Additional relevant MeSH terms:
Iopromide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014