Magnetic Resonance ImagingPhase 3NCT01050829
Gadobutrol Magnevist-controlled Body Study
A Phase 3 study testing Gadobutrol (Gadovist, BAY86-4875) and Gadopentetate Dimeglumine (Magnevist, BAY86-4882) in people with Magnetic Resonance Imaging, run by Bayer at 15 sites in 3 countries.
Trial summary
The 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 MR images of the body/extremities regions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- Gadobutrol (Gadovist, BAY86-4875) and Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jan 2010to Apr 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 20 years of age
- Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure
- Is willing to undergo the routine contrast-enhanced MRI examinations
- Is willing and able to complete all study procedures specified in the protocol
- Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist
Who cannot join
- Is a female subject who is pregnant or nursing
- Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study
- Has been previously enrolled in this study or any other study using gadobutrol
- Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
- Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
- Has received any contrast agent within 24 hours prior to the study MRI
Show all 11Show fewer
- Has a glomerular filtration rate value <30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment
- Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
- Has severe cardiovascular disease (eg, acute myocardial infarction (<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (<48 hours)
- Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
- Has any contraindication to Magnevist according to the package insert
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Japan7 sites
Study site
Bunkyo-ku, Tokyo, 113-8431
Study site
Chikushino-shi, Fukuoka, 818-8516
Study site
Fukuoka, Fukuoka, 812-0033
Study site
Kamogawa, Chiba, 296-0041
Study site
Kobe, Hyōgo, 650-0047
Study site
Matsuyama, Ehime, 791-0280
Study site
Sunto, Shizuoka, 411-8777
China6 sites
Study site
Beijing, 100853
Study site
Nanjing, Jiangsu, 210009
Study site
Shanghai, 200032
Study site
Shanghai, 200233
Study site
Suzhou, Jiangsu, 215006
Study site
Xi’an, Shanxi, 710032
About this study
Official title: A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)
The 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 MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- Gadobutrol (Gadovist, BAY86-4875), Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
- Keywords
- Magnetic resonance imaging, Tumor, Contrast media, Gadobutrol
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadovist, BAY86-4875)Drug
Single administration at a dose of 0.1 mmol/kg
Gadopentetate Dimeglumine (Magnevist, BAY86-4882)Drug
Single administration at a dose of 0.1 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadobutrol (Gadovist, BAY86-4875) |
| Arm 2 | Active comparator | Not described Receives: Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.
Measured: At Day 0
Secondary outcomes (3)
Sensitivity and specificity for the detection of malignant lesions
Measured: At Day 0
Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan
Measured: At Day 0
Confidence in diagnosis
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050829
- Sponsor's protocol ID
- 13297
- Status last verified
- Dec 2014
- First submitted
- 13 Jan 2010
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)
- ClinicalTrials.gov ID
- NCT01050829
- Acronym / sponsor ID
- 13297
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Magnetic resonance imaging, Tumor, Contrast media, Gadobutrol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Jan 2010 (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.
The 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 MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gadobutrol (Gadovist, BAY86-4875) |
| Arm 2 | Active comparator | Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is at least 20 years of age
- Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure
- Is willing to undergo the routine contrast-enhanced MRI examinations
- Is willing and able to complete all study procedures specified in the protocol
- Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist
Key exclusion criteria (11 listed)
- Is a female subject who is pregnant or nursing
- Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study
- Has been previously enrolled in this study or any other study using gadobutrol
- Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
- Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
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)Single administration at a dose of 0.1 mmol/kg | Drug | Arm 1 |
| Gadopentetate Dimeglumine (Magnevist, BAY86-4882)Single administration at a dose of 0.1 mmol/kg | Drug | Arm 2 |
Primary outcome
The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.
Time frame: At Day 0
3 secondary outcomes
Sensitivity and specificity for the detection of malignant lesions
Time frame: At Day 0
Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan
Time frame: At Day 0
Confidence in diagnosis
Time frame: At Day 0
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 30 Dec 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 3 countries: 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) and Gadopentetate Dimeglumine (Magnevist, BAY86-4882) in people with Magnetic Resonance Imaging, run by Bayer at 15 sites in 3 countries.
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 5 inclusion and 11 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 30 Dec 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, China, South Korea. 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?
The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology. (time frame: At Day 0). 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 30 Dec 2014.