Computed TomographyPhase 3NCT00244140
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
A Phase 3 study testing Iopromide 370 mg I/mL and Iopromide 300 mg I/mL in people with Computed Tomography and Diagnostic Imaging, run by Bayer at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography, Diagnostic Imaging
- What is being tested?
- Iopromide 370 mg I/mL and Iopromide 300 mg I/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 23 sitesin 4 countries
- Study dates
- Oct 2005to Apr 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
Who cannot join
- 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 locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States17 sites
Study site
Ann Arbor, Michigan, 48109-0030
Study site
Atlanta, Georgia, 30303
Study site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21287
Study site
Boston, Massachusetts, 02114-2696
Study site
Boston, Massachusetts, 02115
Study site
Boston, Massachusetts, 02118
Study site
Charleston, South Carolina, 29425
Study site
Cleveland, Ohio, 44195
Study site
Danville, Pennsylvania, 17822
Study site
Detroit, Michigan, 48201
Study site
Evanston, Illinois, 60201
Study site
Miami, Florida, 33101
Study site
New York, New York, 10016
Study site
Stony Brook, New York, 11794-8460
Study site
Tallahassee, Florida, 32308
Study site
Tucson, Arizona, 85711
South Korea2 sites
Study site
Seoul, Seoul Teugbyeolsi, 110-744
Study site
Seoul, 138-736
About this study
Official title: Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body
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
Read the 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.
- Conditions
- Computed Tomography, Diagnostic Imaging
- Being tested
- Iopromide 370 mg I/mL, Iopromide 300 mg I/mL
- Keywords
- Ultravist 370, CECT, CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopromide 370 mg I/mLDrug
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide 300 mg I/mLDrug
Iopromide (Ultravist 300 mg I/mL) administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Iopromide 370 mg I/mL | Experimental | Iopromide (Ultravist 370 mg I/mL) administered intravenously Receives: Drug: Iopromide 370 mg I/mL |
| Iopromide 300 mg I/mL | Experimental | Iopromide (Ultravist 300 mg I/mL) administered intravenously Receives: Drug: Iopromide 300 mg I/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post administration assessment of study images
Secondary outcomes (3)
The Ability of the Investigator to Make a Diagnosis Based on the CECT Images
The number of participants with diagnostic CECTs as assessed by the investigators.
Measured: post administration assessment of study images
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.
A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.
Measured: post administration assessment of study images
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images
The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.
Measured: post administration assessment of study images
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Computed TomographyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244140
- Sponsor's protocol ID
- 91462
- Other IDs
- 309660
- Status last verified
- Jan 2014
- First submitted
- 24 Oct 2005
- Last updated
- 28 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No