Central Nervous System DiseasesPhase 3NCT00395460
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
A Phase 3 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Magnevist in people with Central Nervous System Diseases, run by Bayer at 4 sites in China.
Trial summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Nervous System Diseases
- What is being tested?
- Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Magnevist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese origin, with known or suspected brain or spine diseases
Who cannot join
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other trial
- Require emergency treatment
- Severely impaired liver and kidney functions
Trial locations and contacts
4 sites in 1 country.
China4 sites
Chinese PLA General Hosp.
Beijing, 100853
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Fudan University Huashan Hospital
Shanghai, 200040
The 1st Affiliated Hosp of the 4th Military Med Uni
Xi'an, Shaanxi, 710032
About this study
Official title: A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
- Conditions
- Central Nervous System Diseases
- Being tested
- Gadobutrol (Gadavist, Gadovist, BAY86-4875), Magnevist
- Keywords
- Gadovist, Gadavist, Contrast agent, Brain, Spine disease, Magnetic Resonance Imaging
- Medical subject headings
- Central Nervous System Diseases, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)Drug
1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)
MagnevistDrug
0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)
| Study group | Role | What they receive |
|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875) | Experimental | Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
| GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) | Active comparator | Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec Receives: Drug: Magnevist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions
CNR = (signal intensity [SI] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.
Measured: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Secondary outcomes (4)
Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan
The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Measured: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment
The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as "improved", "unchanged" or "worsened" for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Measured: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI
The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Measured: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions
Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Measured: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2007
- Study completionApr 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System DiseasesStudies 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
- 147 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
- NCT00395460
- Sponsor's protocol ID
- 91536
- Other IDs
- Project DE 00562, 309761
- Status last verified
- May 2015
- First submitted
- 2 Nov 2006
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients
- ClinicalTrials.gov ID
- NCT00395460
- Acronym / sponsor ID
- 91536
- Conditions
- Central Nervous System Diseases
- Keywords
- Gadovist, Gadavist, Contrast agent, Brain, Spine disease, Magnetic Resonance Imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 3 Nov 2006 (estimated)
- Results
- Posted 1 Nov 2011
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 this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875) | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) |
| GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) | Active comparator | Drug: MagnevistParticipant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chinese origin, with known or suspected brain or spine diseases
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other trial
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 (Gadavist, Gadovist, BAY86-4875)1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW) | Drug | Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875) |
| Magnevist0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW) | Drug | GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) |
Primary outcome
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions
Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
CNR = (signal intensity [SI] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.
4 secondary outcomes
Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan
Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment
Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI
Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions
Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationLiang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28
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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
4 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 (Gadavist, Gadovist, BAY86-4875) and Magnevist in people with Central Nervous System Diseases, run by Bayer at 4 sites in China.
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 7 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions (time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395460, which also lists 1 linked publication.
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 8 Jun 2015.