Magnetic Resonance ImagingPhase 3NCT01660841
Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging
A Phase 3 study testing Gadobutrol (Gadovist, BAY86-4875) in people with Magnetic Resonance Imaging, run by Bayer at 15 sites in Japan.
Trial summary
Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- Gadobutrol (Gadovist, BAY86-4875)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 15 sitesJapan
- Study dates
- Sep 2012to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure
Who cannot join
- Subjects with any contraindication to the MRI examination
- Subjects with severe renal disease to end stage renal disease
- Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Study site
Daitō, Osaka, 574-0074
Study site
Fujisawa, Kanagawa, 251-8550
Study site
Fukuoka, Fukuoka, 810-0001
Study site
Fukuoka, Fukuoka, 811-0213
Study site
Fukuyama, Hiroshima, 720-0825
Study site
Funabashi, Chiba, 274-8503
Study site
Kawasaki, Kanagawa, 210-0013
Study site
Kishiwada, Osaka, 596-8522
Study site
Kitakyushu, Fukuoka, 800-0057
Study site
Kobe, Hyōgo, 650-0047
Study site
Kobe, Hyōgo, 654-0047
Study site
Nagoya, Aichi-ken, 455-8530
Study site
Shimonoseki, Yamaguchi, 750-0061
Study site
Ube, Yamaguchi, 755-0151
Study site
Yokohama, Kanagawa, 226-0025
About this study
Official title: A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)
Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).
- Conditions
- Magnetic Resonance Imaging
- Being tested
- Gadobutrol (Gadovist, BAY86-4875)
- Keywords
- Magnetic resonance imaging, central nervous system, contrast media, gadobutrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadovist, BAY86-4875)Drug
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadobutrol (Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores for visualization parameter: degree of contrast enhancement
Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.
Measured: Day of gadobutrol injection (Day 0)
Scores for visualization parameter: border delineation
Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.
Measured: Day of gadobutrol injection (Day 0)
Scores for visualization parameter: internal morphology
Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.
Measured: Day of gadobutrol injection (Day 0)
Number of detected lesions
Blinded readers determine number of detected lesions in scans with and without gadobutrol.
Measured: Day of gadobutrol injection (Day 0)
Secondary outcomes (4)
Percentage of exact match of the MRI diagnosis with the final clinical diagnosis
An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.
Measured: Day of gadobutrol injection (Day 0)
Sensitivity and specificity to detect abnormal/normal brain tissue
Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.
Measured: Day of gadobutrol injection (Day 0)
Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions
Percentage to correctly detect presence and absence of malignant lesions which are derived from the MR diagnosis of readers when compared with the diagnosis of the independent standard of truth committee.
Measured: Day of gadobutrol injection (Day 0)
Number of participants with treatment emergent adverse events as a measure of safety and tolerability
Measured: 3 days after injection (Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 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
- NCT01660841
- Sponsor's protocol ID
- 16260
- Status last verified
- Sep 2014
- First submitted
- 7 Aug 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)
- ClinicalTrials.gov ID
- NCT01660841
- Acronym / sponsor ID
- 16260
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Magnetic resonance imaging, central nervous system, contrast media, gadobutrol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gadobutrol (Gadovist, BAY86-4875) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure
Key exclusion criteria (3 listed)
- Subjects with any contraindication to the MRI examination
- Subjects with severe renal disease to end stage renal disease
- Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadobutrol (Gadovist, BAY86-4875)A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight. | Drug | Arm 1 |
Primary outcome
Scores for visualization parameter: degree of contrast enhancement
Time frame: Day of gadobutrol injection (Day 0)
Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.
Scores for visualization parameter: border delineation
Time frame: Day of gadobutrol injection (Day 0)
Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.
Scores for visualization parameter: internal morphology
Time frame: Day of gadobutrol injection (Day 0)
Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.
Number of detected lesions
Time frame: Day of gadobutrol injection (Day 0)
Blinded readers determine number of detected lesions in scans with and without gadobutrol.
4 secondary outcomes
Percentage of exact match of the MRI diagnosis with the final clinical diagnosis
Time frame: Day of gadobutrol injection (Day 0)
Sensitivity and specificity to detect abnormal/normal brain tissue
Time frame: Day of gadobutrol injection (Day 0)
Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions
Time frame: Day of gadobutrol injection (Day 0)
Number of participants with treatment emergent adverse events as a measure of safety and tolerability
Time frame: 3 days after injection (Day 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadobutrol (Gadovist, BAY86-4875) in people with Magnetic Resonance Imaging, run by Bayer at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores for visualization parameter: degree of contrast enhancement (time frame: Day of gadobutrol injection (Day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.